BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 50

    MDR report key: 1945729 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-10129
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    DEPUY INT'L., LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE U.S. UNDER A DIFFERENT PART NUMBER. 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 DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A LOT SPECIFIC COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. ALTHOUGH THE ROOT CAUSE CANNOT BE DETERMINED, IT IS KNOWN THAT THE ASR PLATFORM WAS VOLUNTARILY RECALLED IN AUGUST OF 2010 FOLLOWING AN HHE (HEALTH HAZARD EVALUATION). FURTHER ANALYSIS REGARDING THE ASR PRODUCT FAMILY WILL BE DOCUMENTED, AS DETERMINED PERTINENT, IN (B)(4). BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR FURTHER CORRECTIVE ACTION IS NOT INDICATED AT THIS TIME. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A DEPUY ASR RESURFACING HIP PROCEDURE ON (B)(6) 2006. PATIENT HAS BEEN EXPERIENCING TINNITUS AND HEARING REDUCTION FOR THE PAST 7 MONTHS AND HAS ELEVATED COBALT LEVELS. AT TIME OF REVISION SURGERY, THERE WAS EVIDENCE OF TISSUE STAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 50 TOTAL HIP REPLACEMENT KWA DEPUY INT'L., LTD. NA 1967881

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention