BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2121992 · Received June 9, 2011

    Report

    Report Number
    1818910-2011-09889
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL 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

    ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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

    ADDITIONAL INFORMATION: LITIGATION PAPERS ALLEGE THE PATIENT EXPERIENCED PROGRESSIVE PAIN, DISCOMFORT, SORENESS, ELEVATED COBALT AND CHROMIUM LEVELS AND HAD TO BE REVISED. DURING HER LEFT REVISION SURGERY, HER SURGEON ENCOUNTERED A WHITE CREAMY FLUID AND THE SYNOVIUM DEMONSTRATED A THICKENED TAN COLOR WHICH WAS AVASCULAR. A COMPLETE SYNOVECTOMY WAS PERFORMED EXCISING A SIMILAR AVASCULAR THICKENED SYNOVIUM UP TO TWO CENTIMETERS IN THICKNESS AND THE RESECTION OF THIS, PRESUMABLY GRANULOMATIS TISSUE, WAS POSTERIORLY SECONDARY TO THE PROXIMITY OF THE SCIATIC NERVE. HER ACETABULAR CUP HAD THE SAME FINDING OF LARGELY FIBROUS INGROWTH, 60% TO 70%.

    Description of Event or Problem · 1

    BILATERAL PT WAS REVISED TO ADDRESS HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2469363

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention