BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 48

    MDR report key: 3120021 · Received May 20, 2013

    Report

    Report Number
    1818910-2013-05958
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    May 21, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    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. (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

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, PHYSICAL INJURY, BODILY IMPAIRMENT AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013-SALES REP REPORTED REVISION SURGERY ON LEFT HIP DUE TO ELEVATED METAL ION LEVELS. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221998 ASR ACETABULAR CUPS 48 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2109381

    Patients

    Seq Age Sex Outcome Treatment
    1 Other