BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR FEM IMPLANT SZ 43

    MDR report key: 3093957 · Received May 6, 2013

    Report

    Report Number
    1818910-2013-05405
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    August 19, 2010
    Report Date
    January 11, 2012
    Product Code
    KXA
    PMA / PMN Number
    K032659
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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). 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 PENDING. THERE HAS BEEN NO ADDITIONAL INFORMATION GIVEN REGARDING THE ORIGINAL SURGERY OR POSSIBLE REVISION SURGERY. UPDATE - (B)(4) 2012, INFORMATION RECEIVED FROM OUTSIDE COUNSEL. NO INFORMATION PROVIDED AS TO REASON FOR REVISION. UPDATE - (B)(6) 2012, PLAINTIFF'S FACT SHEET (PFS) RECEIVED (B)(4) 2012. CHANGED UNK ASR HIPS TO ASR CUP ADDED FEMORAL HEAD PRODUCT. THERE WAS NO NEW INFORMATION RECEIVED THAT WOULD IMPACT THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197034 DEPUY ASR FEM IMPLANT SZ 43 FEMORAL HEAD HIP IMPLANT KXA 2303690

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention