Events

Rappel de DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis ImplantsModular Centered Epiphysis Size 1 HAModular Eccentric Epiphysis Size 1 Left HAModular Eccentric Epiphysis Size 1 Right HAModular Centered Epiphysis Size 2 HAModular Eccentric Epiphysis Size 2 Left HAModular Eccentric Epiphysis Size 2 Right HA

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-01218-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01218-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    An investigation by johnson & johnson medical determined that certain lots produced in a specific machine were manufactured in a manner in which the post’s diameter is out-of-specification. further investigation determined that the issue is related to the circularity of the cylinder. the circularity issue may cause the epiphysis to interfere with the stem and the two implants (epiphysis and stem) cannot be assembled. six (6) complaints were received worldwide within approximately a one month period. the current complaint rate associated with this failure mode is 0.0260%.If the epiphysis does not assemble to the stem and an alternative device is available, there may be a surgical delay of 15 to 59 minutes.Or, if an alternative implant is not available, the patient’s wound may need to be closed and the patient scheduled for a reoperation when a suitable device is available. note: once the epiphysis is properly assembled to the stem, there is no additional risk to the patient.
  • Action
    1. Users are to inspect the device(s) in your possession to determine if they possess affected product. If so quarantine this product prior to returning it to JJM. Return a copy of the supplied completed acknowledgement form as directed. 2. Return any affected product within 30 business days, by contacting JJM Customer Service on 1300 562 711. You may wish to request assistance from your JJM DePuy Synthes Representative. 3. Forward this notice to anyone in your facility who needs to be informed. 4. If any potentially affected product(s) has been forwarded to another facility, contact that facility to arrange inspection and return (if applicable). 5. Keep a copy of the customer letter until actions are completed. 6. JJM will also write to implanting surgeons to advise them of this and the non-risk it presents to implanted devices.

Device

DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis ImplantsModular Cent...
  • Modèle / numéro de série
    DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis ImplantsModular Centered Epiphysis Size 1 HAModular Eccentric Epiphysis Size 1 Left HAModular Eccentric Epiphysis Size 1 Right HAModular Centered Epiphysis Size 2 HAModular Eccentric Epiphysis Size 2 Left HAModular Eccentric Epiphysis Size 2 Right HAMultiple Part and Lot NumbersARTG Number: 143529
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes