BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +2

    MDR report key: 4912944 · Received July 14, 2015

    Report

    Report Number
    1818910-2015-25636
    Event Type
    Injury
    Date Received
    July 14, 2015
    Date of Event
    June 11, 2015
    Report Date
    July 20, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. (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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. USER FACILITY REPORT IS NOW ATTACHED. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: THIS HIP REPLACEMENT PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET AND THE PRODUCT CODES ARE NOW CONSIDERED INACTIVE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION PAPERS ALLEGE: BILATERAL PATIENT WAS IMPLANTED WITH DEPUY ASR HIP IMPLANTS IN (B)(6) 2007 (LEFT SIDE) AND AGAIN IN (B)(6) 2008 (RIGHT SIDE). THE ACETABULAR CUP EVENTUALLY CAUSED METALLIC DEBRIS AND/OR LOOSENED FROM PATIENT'S ACETABULUM, CAUSED PAIN, AND INHIBITED PATIENT'S ABILITY TO WALK. PATIENT WAS REQUIRED TO UNDERGO REVISION SURGERY. UPDATE REC'D 6/19/2015 - MEDWATCH REPORT (B)(4) RECEIVED. PATIENT HAD REVISION OF LEFT TOTAL HIP REPLACEMENT FOR REMOVAL OF A DEPUY ASR ARTICULAR LINER. COMPONENT IDENTIFIED AS FOLLOWS: ACETABULAR CUP, (B)(4); LOT 2177776; SIZE 54, EXP 2011-06; FEMORAL IMPLANT, (B)(4); LOT 2192251; SIZE 47, EXP. 2011-07.

    Description of Event or Problem · 1

    AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESSED FAILED LEFT TOTAL HIP REPLACEMENT AND ARTICULAR WEAR RESULTING TO ELEVATED METAL IONS. OPERATIVE FINDING REPORTED MILD FLUID, MILD METAL STAINING, DEBRIS AND TRUNNION INTERFACE AND GRAY STAINING OF TISSUE CONSISTENT WITH "METALOSIS". OPERATIVE NOTE REPORTED CLOUDY FLUID WAS OBTAINED AND WAS SENT FOR METAL IONS ANALYSIS. THERE WAS SOME BLACK GRAY STAINING OF THE SYNOVIAL LINING, BLACK DEBRIS AT THE TRUNNION AND A TINY AMOUNT OF GRAY STAINED MEMBRANE BEHIND THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455657 ADAPTER SLEEVES 12/14 +2 HIP OTHER IMPLANT KWA DEPUY ORTHOPAEDICS, INC. 1818910 2254144

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention