BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 44

    MDR report key: 2418405 · Received January 17, 2012

    Report

    Report Number
    1818910-2012-00860
    Event Type
    Injury
    Date Received
    January 17, 2012
    Report Date
    January 12, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510K# SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE US. 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

    THIS REPORT WAS FOUND TO BE A DUPLICATE OF 181890-2011-20047.

    Description of Event or Problem · 1

    ASR REVISION. REASON(S) FOR REVISION: PAIN, FROM (B)(6) ATTACHED BELOW INJURIES ATTRIBUTED TO A REACTION OF SOFT TISSUE, INCREASING LEVELS OF COBALT AND CR IN THE PATIENTS BLOOD. BESIDE THIS ALL RESULTS WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 44 ACETABULAR CUP KWA DEPUY INTERNATIONAL 1238173

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention