BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR FEM IMPLANT SZ 46

    MDR report key: 2162240 · Received July 7, 2011

    Report

    Report Number
    1818910-2011-12423
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 9, 2010
    Report Date
    June 7, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KXA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: THE PATIENT WAS REVISED BECAUSE THE CUP WAS PUT IN OVERLY ANTEVERTED AND BECAME LOOSE. DOI: UNKNOWN DOR: (B)(6) 2010 (LEFT SIDE). UPDATE: 06/07/2010 - LITIGATION PAPERS ALLEGE THE FOLLOWING: PATIENT WAS FORCED TO UNDERGO A REVISION SURGERY IN OR AROUND (B)(6) 2010 AFTER SHE EXPERIENCED A LOOSENING OF THE ACETABULAR COMPONENT. PATIENT UNDERWENT ANOTHER PROCEDURE FOR LEFT HIP DISLOCATION IN OR AROUND (B)(6) 2010. PATIENT SUFFERED AND/OR WILL SUFFER PAIN, INHIBITION OF THE ABILITY TO WALK, UNNECESSARY AND ADDITIONAL SURGERY, AND OTHER INJURIES PRESENTLY UNDIAGNOSED. FEMORAL HEAD ADDED TO THE COMPLAINT. DOI OF (B)(6) 2008 IS IN THE LITIGATION PAPERS. PATIENT IS A RESIDENT OF (B)(6). 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. WWCAPA (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 COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE THE CUP WAS PUT IN OVERLY ANTEVERTED AND BECAME LOOSE. UPDATE (B)(6) 2010 - LITIGATION PAPERS ALLEGE THE FOLLOWING: PT WAS FORCED TO UNDERGO A REVISION SURGERY IN OR AROUND (B)(6) 2010 AFTER SHE EXPERIENCED A LOOSENING OF THE ACETABULAR COMPONENT. PT UNDERWENT ANOTHER PROCEDURE FOR LEFT HIP DISLOCATION IN OR AROUND (B)(6) 2010. PT SUFFERED AND/OR WILL SUFFER PAIN, INHIBITION OF THE ABILITY TO WALK, UNNECESSARY AND ADDITIONAL SURGERY, AND OTHER INJURIES PRESENTLY UNDIAGNOSED. FEMORAL HEAD ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR FEM IMPLANT SZ 46 TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL, LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention