BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2241597 · Received September 9, 2011

    Report

    Report Number
    1818910-2011-17759
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    January 6, 2014
    Report Date
    January 6, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE ON OR ABOUT VARIOUS DATES POST-SURGICALLY, PATIENT SUFFERED DISCOMFORT, PAIN, AND SORENESS, WHICH IN TURN NEGATIVELY AFFECTED PATIENTS ABILITY TO WALK, MOVE, SIT, AND SLEEP. PATIENT 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. PATIENT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2014 - SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 ACETABULAR CUP KWA DEPUY INTERNATIONAL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention