BEUDAMED
    FDA Recall Terminated

    PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.

    Recall: Z-1077-2014 · Initiated December 9, 2013

    Recall

    Recall Number
    Z-1077-2014
    Event Number
    67159
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 9, 2013
    Posted
    February 24, 2014
    Terminated
    June 10, 2014
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.

    Reason

    Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants to fracture under what would normally be acceptable loads.

    Action

    The recall is extended to the DePuy Distributor, Hospital, and Surgeon levels. The two affected distributors were contacted by telephone. Written communication to the two hospitals and one surgeon who received the devices will be delivered by DePuy Orthopaedics, Inc. via email or regular mail. The one affected surgeon will also be contacted by telephone by the Medical Safety Officer and a metallurgist, who will discuss the surgeon communication with the surgeon. The sales representatives aid customers in the affected device returns, as needed. The devices will be returned through the normal DePuy Returns process, to attention of Returns and marking H13-30C on the outside of the box. All (21) remaining devices have been verified as being returned and in quarantine. Effectiveness will be determined by product reconciliation, receipt of all hospital reconciliation forms, and receipt of international declaration from the International Affiliate. DePuy will follow-up with the affected hospitals until all hospital reconciliation forms are returned, and DePuy will follow-up with the International Affiliate until all international actions are complete and the international declaration is completed and return.

    Distribution

    Worldwide Distribution-USA including the states of IA, CA, KY, and FL, and the countries of Finland, Germany, Sweden, and Czech Republic.

    Quantity

    2