BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 64

    MDR report key: 3233670 · Received July 18, 2013

    Report

    Report Number
    1818910-2013-21531
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    March 28, 2013
    Report Date
    July 5, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. 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). 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

    FURTHER EVALUATION OF THE PRODUCT CODE INDICATES THAT THIS PARTICULAR SIZE WAS NOT REGULATED TO BE SOLD IN THE US. THEREFORE, THIS REPORT IS BEING REJECTED.

    Description of Event or Problem · 1

    REASON(S) FOR REVISION: PAIN, ALVAL / SOFT TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334868 ASR ACETABULAR IMPLANT 64 ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2251257

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention