BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 46

    MDR report key: 2113125 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-08755
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: CORRECTION/REMOVAL REPORTING NUMBER. 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

    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).

    Additional Manufacturer Narrative · 1

    LITIGATION PAPERS ALLEGE THE PATIENT HAS SUFFERED PHYSICAL PAIN; DISFIGUREMENT; ANXIETY, LOSS OF LIFES PLEASURES; GAIT AND/OR LEG LENGTH DISCREPANCY, WEAKNESS AND GIVING WAY; KNEE AND JOINT AGGRAVATION AND INJURY; COLITIS AND BOWEL INJURY; DAMAGE TO THE TISSUES AND STRUCTURE OF THE HIP; INFLAMMATORY AND LYMPHOCYTIC RESPONSE TO METAL ON METAL HIP IMPLANT; SYNOVITIS; MECHANICAL COMPLICATIONS LEFT TOTAL HIP REPLACEMENT; HYPERACTIVE SYNOVIUM; BURSAL AND JOINT SCARRING; METALLOSIS; WEAKNESS; IMBALANCE; CHROMIUM AND COBALT TOXICITY AND AVASCULAR NECROSIS AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT. THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS METALLOSIS AND VERTICAL CUP POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 46 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2541792

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention