Avis De Sécurité sur Biolox Delta Ceramic Head 32mm Standard Neck type 1 taper

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Biomet UK Ltd.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2016-03-29
  • Pays de l'événement
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    This notice is to inform you of an urgent field safety corrective action that has been initiated by biomet uk ltd which involves the biolox delta ceramic head implants referenced above. our records show that the implants may have been distributed to your hospital. we are requesting that you immediately locate and discontinue use of any implants with the above listed reference/lot number combinations. the ceramic heads are designed to be used with biomet femoral stems in total hip joint replacement surgery procedures comprising of a ceramic femoral head component articulating against either a ceramic insert fitted into a cementless acetabular shell or against ultra-high molecular weight polyethylene (uhmwpe) cups. biomet uk ltd has initiated this action following an investigation that has revealed that a product packaging labelled as biolox delta ceramic head 36mm standard neck type 12/14 taper (reference 650-0837/lot no. 2015051321) contained a biolox delta ceramic head 32mm standard neck type 1 taper, reference 650-1162 with serial number 5064122 engraved. review of internal records revealed that the biolox delta ceramic head 32mm standard neck type 1 taper with serial number 5064122 engraved, is used for the manufacturing of several lot numbers of reference 650-1162 biolox delta ceramic heads 32mm standard neck type 1 taper. the lot numbers 2015051327, 2015051328, 2015051329, 2015051214 were manufactured at at the same time as the biolox delta ceramic head 36mm standard neck type 12/14 taper (reference 650-0837/lot no. 2015051321). as it cannot be determined based on current available data which of the above 4 listed lots of the biolox delta ceramic head 32mm standard neck type 1 taper, reference 650 1162 contains a biolox delta ceramic head 36mm standard neck type 12/14 taper (reference 650-0837/lot no. 2015051321) biomet uk itd decided to recall all above listed lots as a precautionary measure. due to the ceramic heads having different size/angle tapers as well different head diameters, it is highly likely that this issue would be detected by the surgeon and theatre staff upon opening the box and checking the biolox delta ceramic head. in the unlikely event that it is not identified during the box opening process then the taper would not be compatible with the stem and the head would not fit to the liner correctly which would be very obvious to the surgeon. the most likely effect is therefore considered to be a delay to surgery whilst the surgeon sources another ceramic head. has initiated this action following an investigation that has revealed that a product packaging labelled as biolox delta ceramic head 36mm standard neck type 12/14 taper (reference 650-0837/lot no. 2015051321) contained a biolox delta ceramic head 32mm standard neck type 1 taper, reference 650-1162 with serial number 5064122 engraved. review of internal records revealed that the biolox delta ceramic head 32mm standard neck type 1 taper with serial number 5064122 engraved, is used for the manufacturing of several lot numbers of reference 650-1162 biolox delta ceramic heads 32mm standard neck type 1 taper. the lot numbers 2015051327, 2015051328, 2015051329, 2015051214 were manufactured at at the same time as the biolox delta ceramic head 36mm standard neck type 12/14 taper (reference 650-0837/lot no. 2015051321). as it cannot be determined based on current available data which of the above 4 listed lots of the biolox delta ceramic head 32mm standard neck type 1 taper, reference 650 1162 contains a biolox delta ceramic head 36mm standard neck type 12/14 taper (reference 650-0837/lot no. 2015051321) biomet uk itd decided to recall all above listed lots as a precautionary measure. due to the ceramic heads having different size/angle tapers as well different head diameters, it is highly likely that this issue would be detected by the surgeon and theatre staff upon opening the box and checking the biolox delta ceramic head. in the unlikely event that it is not identified during the box opening process then the taper would not be compatible with the stem and the head would not fit to the liner correctly which would be very obvious to the surgeon. the most likely effect is therefore considered to be a delay to surgery whilst the surgeon sources another ceramic head. .

Device

  • Modèle / numéro de série
    2015051327, 2015051328, 2015051329, 2015051214, 2015051321
  • Manufacturer

Manufacturer

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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.
  • Source
    AMPMDRS