BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 2912331 · Received January 11, 2013

    Report

    Report Number
    1818910-2013-00463
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 23, 2011
    Report Date
    August 24, 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
    NY, 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. (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

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED INCREASINGLY DEBILITATING PAIN, DISCOMFORT, AND SORENESS, AS WELL AS INSTABILITY AND A SENSATION OF HIS HIP IMPLANT GIVING OUT, WHICH IN TURN NEGATIVELY AFFECTED THE PATIENTS ABILITY TO WALK, MOVE, AND SLEEP, AND REQUIRED THE USE OF A CANE. PAPERS FURTHER ALLEGE THE PATIENT WAS FOUND TO HAVE ELEVATED COBALT AND CHROMIUM ON (B)(4) 2011. DURING THE REVISION SURGERY, HIS ORTHOPEDIST ENCOUNTERED A LOT OF FLUID ACCUMULATION AND AN ENORMOUS AMOUNT OF SOFT TISSUE REACTION AND DEBRIS REQUIRING EXTENSIVE DEBRIDEMENT AND SYNOVECTOMY. ADDITIONALLY, DURING THE REVISION SURGERY THERE WAS FOUND TO BE A LOT OF BLACK CORROSION AT THE TRUNNION AND IN THE JOINT IN THE HIP BALL AND UPON EXAMINATION OF THE CUP THERE DID NOT APPEAR TO BE GOOD BONY INGROWTH. AREAS OF OSTEOLYSIS IN THE ACETABULUM REQUIRED DEBRIDEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17970 ASR ACETABULAR CUPS 52 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL 2345216

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention