BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +2

    MDR report key: 3042592 · Received April 9, 2013

    Report

    Report Number
    1818910-2013-06484
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 13, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    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

    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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE ACETABULAR CUP EVENTUALLY DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM PATIENTS ACETABULUM, CAUSED SEVERE PAIN, INHIBITED PATIENTS ABILITY TO WALK, AND WILL LIKELY REQUIRE A REVISION SURGERY. DOI: (B)(6) 2008 - DOR: NONE REPORTED (RIGHT HIP). **UPDATE** (B)(4) 2012 - PATIENT FACT SHEET WAS RECEIVED. THE PART/LOT NUMBERS HAVE BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THIS COMPLAINT IS CLOSED AT THIS TIME. **UPDATE**(B)(4) 2013 - MEDICAL RECORDS RECEIVED. MEDICAL RECORDS INDICATED THAT METAL SYNOVITIS WAS NOTED INTEROPERATIVE. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144993 ADAPTER SLEEVES 12/14 +2 SLEEVE KWA DEPUY INTERNATIONAL 2519990

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention