BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR CUP

    MDR report key: 2892723 · Received January 2, 2013

    Report

    Report Number
    1818910-2013-00551
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    September 5, 2012
    Report Date
    December 12, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). LITIGATION ALLEGES PATIENT HAD PAIN, STIFFNESS, DISCOMFORT AND WEAKNESS WHICH NEGATIVELY AFFECT MOBILITY; TOXICITY OF METAL IN THE BODY; AND THE ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES IS LIMITED AFTER ASR HIP IMPLANT. REVISION SURGERY FOUND SOME GRAYISH TISSUE IN THE SYNOVIUM AND THAT THE ACETABULAR COMPONENT HAD MINIMAL BONE GROWTH. DEPUY STILL 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

    PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE THAT THE PATIENT WAS REVISED TO ADDRESS DISCOMFORT AND GROIN PAIN AND INCREASED COBALT AND CHROMIUM LEVELS. NOTED WAS LITTLE BONE INGROWTH OF THE ACETABULAR COMPONENT AND GRAY SYNOVIAL TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757 UNKNOWN DEPUY ASR CUP CUP KWA DEPUY INTERNATIONAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention