BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 3133794 · Received May 29, 2013

    Report

    Report Number
    1818910-2013-05424
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    January 10, 2011
    Report Date
    January 17, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LEGAL CLAIM FORWARDED TO CUSTOMER QUALITY FOR REVIEW. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. ***UPDATE*** 1/17/2012 PLAINTIFF'S FACT SHEET (PFS) RECEIVED (B)(6) 2012. CHANGED UNK ASR HIP TO ASR CUP ADDED FEMORAL HEAD. THERE WAS NO NEW INFORMATION RECEIVED THAT WOULD IMPACT THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236812 ASR UNI FEMORAL IMPL SIZE 49 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2446660

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention