BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 3230623 · Received July 16, 2013

    Report

    Report Number
    1818910-2013-21378
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 11, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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

    IT HAS BEEN REPORTED PATIENT UNDERWENT REVISION PROCEDURE OF LEFT HIP DUE TO SIGNIFICANT METALLOSIS SEEN IN SOFT TISSUE/CAPSULE ALONG TROCHANTER AND DOWN THE FEMORAL CANAL OF CORAIL IMPLANT. ALSO REPORTED LOOSENING OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329086 ASR ACETABULAR CUPS 54 ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2323973

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention