BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2121993 · Received June 9, 2011

    Report

    Report Number
    1818910-2011-09887
    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

    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.

    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

    BILATERAL PT WAS REVISED TO ADDRESS HIP PAIN.

    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 RIGHT HIP REVISION, PAPERS ALLEGE THE PATIENTS ORTHOPEDIC SURGEON ENCOUNTERED CREAMY WHITE FLUID AND THE SYNOVIUM DEMONSTRATED AN ACUTE AND CHRONIC INFLAMMATORY APPEARANCE WITH A THICKENED GRANULOMATOUS-APPEARING MATERIAL OF WHICH APPEARED A TAN COLOR AND AVASCULAR. HE PERFORMED A COMPLETE SYNOVECTOMY EXCISING A MASS OF THICKENED CAPSULE ANTEROMEDIAL APPROXIMATELY TWO CENTIMETERS IN THICKNESS, EXCISING AS MUCH OF THIS GRANULOMATOUS MATERIAL AS POSSIBLE BUT WAS FORCED TO LEAVE SOME MATERIAL DUE TO THE PROXIMITY TO THE SCIATIC NERVE. HER RIGHT ACETABULAR CUP WAS FOUND TO HAVE MINIMAL BONY INGROWTH WITH LARGELY FIBROUS TISSUE ADHERENT TO 60% TO 70% OF THE SURFACE AREA OF THE SHELL. SINCE HER REVISION SURGERY, THE PATIENT CONTINUES TO HAVE WEAKNESS ON HER RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2731625

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention