BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 3232992 · Received July 18, 2013

    Report

    Report Number
    1818910-2013-21511
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    July 16, 2013
    Report Date
    October 15, 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
    AZ, 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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    **UPDATE**(B)(4) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES TROCHANTERIC FLUID, IMPLANT FAILURE, METALLOSIS AND PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: ELEVATED COBALT CHROME LEVELS; STIFFNESS IN THE HIP; SOME PAIN; METALLOSIS; LARGE PSEUDOCAPSULE WITH FLUID; FAIR AMOUNT OF SCARRING. WITH INFORMATION PROVIDED, INVOICE WAS LOCATED. LOT NUMBERS ARE BEING REPORTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REVISION PROCEDURE OF RIGHT HIP DUE TO PSEUDOCAPSULE, SCAR TISSUE, ELEVATED ION LEVELS, AND BLACKENED TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332975 ASR UNI FEMORAL IMPL SIZE 49 FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2383641

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention