BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 62

    MDR report key: 2943597 · Received February 5, 2013

    Report

    Report Number
    1818910-2013-03781
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    August 22, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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. REF. (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

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    LEGAL CLAIM ALLEGES THAT THE PATIENT WILL REQUIRE REVISION SURGERY. UPDATE: (B)(4) 2013-SALES REP REPORTED REVISION SURGERY DUE TO HIGH METAL LEVELS AND PAIN. PART/LOT WAS IDENTIFIED.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013-LEGAL CLAIM RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM DISABILITY, DEFORMITY, AND PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48494 ASR ACETABULAR CUPS 62 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2452466

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention