BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 50

    MDR report key: 2243201 · Received September 12, 2011

    Report

    Report Number
    1818910-2011-17586
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    March 23, 2010
    Report Date
    September 7, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    ATTORNEY

    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. (B)(4).

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS MICROMOTION. ALTHOUGH THE ACETABULAR CUP WAS LEFT IN SITU, IT WAS REPORTED THAT THE PATIENT ALSO HAS EXCESSIVE COBALT LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 50 ACETABULAR CUP IMPLANT KWA DEPUY INTERNATIONAL 2740027

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention