BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2020046 · Received March 11, 2011

    Report

    Report Number
    1818910-2011-04084
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 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
    LA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    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

    THE PATIENT TAKES REMICADE TO BLOCK TNF ALPHA PROTEINS. IN HIS RESEARCH, THE PATIENT HAS LEARNED THAT ELEVATED COBALT/CHROMIUM LEVELS INCREASE TNF ALPHA PROTEINS. HE IS CONCERNED THAT THIS MAY DECREASE THE EFFECTIVENESS OF HIS RA MEDICATION ON HIS SYSTEMIC DISEASE. ASR REPLACED WITH PINNACLE GRIPTION SECTOR/BIOLOX DELTA TS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention NA.