BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED ASR TAPER SLEEVE

    MDR report key: 5319330 · Received December 22, 2015

    Report

    Report Number
    1818910-2015-38093
    Event Type
    Injury
    Date Received
    December 22, 2015
    Date of Event
    June 26, 2009
    Report Date
    December 15, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. ¿ 8010379
    Product Code
    KWY
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    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). D PUY 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

    ADDITIONAL NARRATIVE:ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE DEVICE IS NOT CONTRIBUTING TO THE ISSUE THEREFORE THIS REPORT IS BEING REJECTED.

    Description of Event or Problem · 1

    ASR REVISION, ASR RESURFACING- RIGHT, REASON(S) FOR REVISION: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845159 UNIDENTIFIED ASR TAPER SLEEVE HIP FEMORAL STEM/SLEEVE KWY DEPUY INTERNATIONAL LTD. ¿ 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other