BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 4233899 · Received November 6, 2014

    Report

    Report Number
    1818910-2014-31400
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    February 15, 2011
    Report Date
    October 13, 2014
    Manufacturer
    DEPUY INTL., LTD - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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 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. UDI: (B)(4).

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. THE MEDICAL RECORDS SHOW THE PATIENT WAS IMPLANTED WITH AN ASR LEFT HIP ON (B)(6) 2008. THE PATIENT HAD A REVISION OPERATION ON (B)(6) 2011 FOR A FAILED HIP AND LOOSE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712835 ASR ACETABULAR CUPS 58 HIP ACETABULAR CUP KWA DEPUY INTL., LTD - 8010379 2538237

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention