BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LCCK FEMORAL COMPONENT

    MDR report key: 5306560 · Received December 17, 2015

    Report

    Report Number
    1822565-2015-02679
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Date of Event
    November 20, 2015
    Report Date
    February 28, 2017
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    PMA / PMN Number
    PK960279
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING AMENDED TO REFLECT CHANGES. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. VISUAL INSPECTION OF THE RETURNED COMPONENT CONFIRMED THAT THE CARTON IS CREASED AND DAMAGED ON ALL SIDES, AND BOTH THERMAL CAVITIES ARE CRACKED. THE DEVICE HISTORY RECORDS FOR THE 00-5994-017-91, LOT # 61236351 WERE REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE IDENTIFIED. THIS DEVICE IS USED FOR TREATMENT. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINT FOR LOT#61236351. THE MOST LIKELY ROOT CAUSE OF THE PRODUCT DAMAGE APPEARS TO BE CAUSED BY TRANSIT BUT THE COMPLAINT IS STILL BEING INVESTIGATED UNDER A CAPA AT THIS TIME. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT PACKAGING WAS DAMAGED AND THE STERILITY OF THE IMPLANT WAS CONSIDERED COMPROMISED. SURGERY WAS COMPLETED WITH A DIFFERENT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835950 NEXGEN LCCK FEMORAL COMPONENT JWH JWH ZIMMER INC 61236351

    Patients

    Seq Age Sex Outcome Treatment
    1