BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +8

    MDR report key: 2864583 · Received December 10, 2012

    Report

    Report Number
    1818910-2012-24840
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    May 2, 2012
    Report Date
    August 22, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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 ALLEGES THAT THE PATIENT SUFFERED PAIN, DISCOMFORT, SORENESS, AS WELL AS A GRINDING SENSATION, WHICH BECAME CONSTANT AND WHICH NEGATIVELY AFFECTED HIS ABILITY TO WALK, MOVE, SIT AND STAND. DURING REVISION SURGERY, BROWNISH FLUID EMANATED FROM THE JOINT AND UPON REMOVAL OF THE ACETABULAR CUP THERE WAS NO EVIDENCE OF BONE IN-GROWTH. THE SURGEON NOTICED THAT THERE WAS CORROSION AT THE TRUNNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTER SLEEVES 12/14 +8 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2499577

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention