BEUDAMED
    FDA Adverse Event Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2140898 · Received April 8, 2011

    Report

    Report Number
    1818910-2011-06279
    Date Received
    April 8, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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

    **UPDATE** 01/10/2012: PATIENT FACT SHEET FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    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

    LITIGATION PAPERS ALLEGE THE PT BEGAN EXPERIENCING SYMPTOMS INCLUDING BUT NOT LIMITED TO, HARSH PAIN, DISCOMFORT AND SORENESS, WHICH IN TURN NEGATIVELY AFFECTED HIS ABILITY TO WALK, MOVE AND SLEEP. IT IS FURTHER ALLEGED THAT DUE TO THE METAL ON METAL ABRASION CREATED BY THE DEVICES THE PT IS AT A RISK FOR INJURIES ASSOCIATED WITH METALLOSIS AND TOXICITY OF FOREIGN METAL PARTICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 2160011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA