BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR CUP

    MDR report key: 2163370 · Received July 8, 2011

    Report

    Report Number
    1818910-2011-12262
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 8, 2011
    Manufacturer
    DEPUY INTL, LTD
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH STATES: FEMALE PT WHO HAD A RIGHT TOTAL HIP ARTHROPLASTY WITH ASR AND THERE WAS CONCERN OF SOME METALLOSIS AND PROBLEMS STEMMING FROM HER HIP. PRE-POSTOPERATIVE DIAGNOSIS WAS "FAILED RIGHT TOTAL HIP ARTHROPLASTY ASR CUP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR CUP TOTAL HIP REPLACEMENT KWA DEPUY INTL, LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention