BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 2232013 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-16866
    Event Type
    Injury
    Date Received
    September 1, 2011
    Report Date
    August 4, 2011
    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
    NC, US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: IT WAS REPORTED THAT THE BILATERAL PATIENTS HIPS SQUEAK WHEN HE WALKS. NO IMPLANTS HAVE BEEN REMOVED AT THIS TIME. DOI: (B)(6) 2006. UPDATE - (B)(6) 2011 - LITIGATION PAPERS ALLEGE PATIENT SUFFERED INJURIES WHICH INCLUDED BUT NOT LIMITED TO GRINDING, METAL FLAKES IN AND AROUND THE SOCKET, FLUID, PAIN, SWELLING, LIMITED RANGE OF MOTION. THE PLAINTIFF COULD NOT HAVE KNOWN THAT HE/SHE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT UNTIL AFTER THE DATE HE/SHE HAD HIS/HER BLOOD DRAWN AND HE/SHE WAS ADVISED OF THE RESULTS OF SAID BLOOD-WORK. (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. (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

    IT WAS REPORTED THAT THE BILATERAL PATIENTS HIPS SQUEAK WHEN HE WALKS. NO IMPLANTS HAVE BEEN REMOVED AT THIS TIME. UPDATE - (B)(6) 2011 - LITIGATION PAPERS ALLEGE PATIENT SUFFERED INJURIES WHICH INCLUDED BUT NOT LIMITED TO GRINDING, METAL FLAKES IN AND AROUND THE SOCKET, FLUID, PAIN, SWELLING, LIMITED RANGE OF MOTION. THE PLAINTIFF COULD NOT HAVE KNOWN THAT HE/SHE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT UNTIL AFTER THE DATE HE/SHE HAD HIS/HER BLOOD DRAWN AND HE/SHE WAS ADVISED OF THE RESULTS OF SAID BLOOD-WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 52 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2105500

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention