“The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada
Description du dispositif
ZIMMER UNI HIGH FLEX PRECOAT FEM || prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer || various sizes || These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees."
Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada
Description du dispositif
NexGen LPS Flex Option Femoral || NexGen LPS Flex Precoat Femoral || prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing || various sizes || "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR-Flex and LPS-Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral and tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only. " Specific uses with CR-Flex or LPS-Flex femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong¿ Highly Crosslinked Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees. " Specific Uses with NexGen LPS or LCCK femorals: The LPS femoral is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 130 degrees. The usage of the LCCK femoral is the same as the LPS with the exception that femoral bone loss can be accommodated by femoral stem extensions and augmentation. No varus/valgus constraint or other stability other than that provided by the NexGen LPS is provided when the LCCK femoral component is used with the LPS-Flex articular surfaces."
Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada
Description du dispositif
Gender PFJ FEMORAL COMP, || prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer || various sizes || " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only."
Product 2 consists of all products product code LPH, and same usage: || 801802202 12/14 COCR FEMORAL HEAD 2 || 801802220 12/14 COCR FEMORAL HEAD 2 || 801802230 12/14 COCR FEMORAL HEAD 2 || 801802601 12/14 COCR FEMORAL HEAD 2 || 801802602 12/14 COCR FEMORAL HEAD 2 || 801802603 12/14 COCR FEMORAL HEAD 2 || 801802604 12/14 COCR FEMORAL HEAD 2 || 801802605 12/14 COCR FEMORAL HEAD 2 || 801802801 12/14 COCR FEMORAL HEAD 2 || 801802802 12/14 COCR FEMORAL HEAD 2 || 801802803 12/14 COCR FEMORAL HEAD 2 || 801802805 12/14 COCR FEMORAL HEAD 2 || 801802814 12/14 COCR FEMORAL HEAD 2 || 801803201 12/14 COCR FEMORAL HEAD 3 || 801803202 12/14 COCR FEMORAL HEAD 3 || 801803203 12/14 COCR FEMORAL HEAD 3 || 801803205 12/14 COCR FEMORAL HEAD 3 || 801803214 12/14 COCR FEMORAL HEAD 3 || 801803601 12/14 COCR FEMORAL HEAD 3 || 801803602 12/14 COCR FEMORAL HEAD 3 || 801803603 12/14 COCR FEMORAL HEAD 3 || 801803604 12/14 COCR FEMORAL HEAD 3 || 801803605 12/14 COCR FEMORAL HEAD 3 || 801804001 12/14 COCR FEMORAL HEAD 4 || 801804002 12/14 COCR FEMORAL HEAD 4 || 801804003 12/14 COCR FEMORAL HEAD 4 || 801804004 12/14 COCR FEMORAL HEAD 4 || 902602100 6 DEGREE COCR FEM HEAD 22 || 32902603935 FEM HD 26MMDIA SHT NK+ || 32902603800 FEMORAL HEAD +0.5 X 22 MM || 32902604810 FEMORAL HEAD +3.5 X 22 MM || 32902604845 FEMORAL HEAD +7.0 X 22 MM || For use in total or hemi hip arthroplasty
Product 3 consists of all products under product code JDI, and same usage: || Item no:781803800 12/14 UNIPOLAR FEMORAL HE || 781804000 12/14 UNIPOLAR FEMORAL HE || 781804100 12/14 UNIPOLAR FEMORAL HE || 781804200 12/14 UNIPOLAR FEMORAL HE || 781804300 12/14 UNIPOLAR FEMORAL HE || 781804400 12/14 UNIPOLAR FEMORAL HE || 781804500 12/14 UNIPOLAR FEMORAL HE || 781804600 12/14 UNIPOLAR FEMORAL HE || 781804700 12/14 UNIPOLAR FEMORAL HE || 781804800 12/14 UNIPOLAR FEMORAL HE || 781804900 12/14 UNIPOLAR FEMORAL HE || 781805000 12/14 UNIPOLAR FEMORAL HE || 781805100 12/14 UNIPOLAR FEMORAL HE || 781805200 12/14 UNIPOLAR FEMORAL HE || 781805300 12/14 UNIPOLAR FEMORAL HE || 781805400 12/14 UNIPOLAR FEMORAL HE || 781805500 12/14 UNIPOLAR FEMORAL HE || 781806300 12/14 UNIPOLAR FEMORAL HE || 781809900 12/14 UNIPOLAR FEMORAL HE || 781809901 12/14 UNIPOLAR FEMORAL HE || 781809902 12/14 UNIPOLAR FEMORAL HE || Product For use in total or hemi hip arthroplasty