BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 50

    MDR report key: 2211720 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-15201
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    January 25, 2012
    Report Date
    September 10, 2012
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    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.

    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

    DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    CORRECTED/UPDATED DATA: (DATE OF EVENT); (DATE OF REPORT); (EVENT DESCRIPTION); (IMPLANT DATE); (EXPLANT DATE); (DATE RECEIVED BY MANUFACTURER). DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    ASR REVISION RECOMMENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON THE ASR XL RIGHT ACETABULAR SYSTEM. THE REASON FOR THE REVISION WAS PAIN AND NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 50 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 1967878

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention