BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 3982002 · Received August 5, 2014

    Report

    Report Number
    1818910-2014-25073
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    October 15, 2013
    Report Date
    July 15, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION. LEGAL CLAIM RECEIVED (B)(6) /2014. UPDATE REC¿D (B)(6) 2014 - LITIGATION RECEIVED. LITIGATION ALLEGES ELEVATED METAL ION LEVELS, MEASURED AT 9.9 NG/ML COBALT, 8.3 NG/ML CHROMIUM IN NOVEMBER 2010, 5.2 NG/ML COBALT AND 8.3NG/ML CHROMIUM IN (B)(6) 2012, 4.5NG/ML COBALT AND 5.4NG/ML CHROMIUM MEASURED (B)(6) 2013; PAIN, A CLICKING NOISE, AND DAMAGED TISSUE AND MUSCLES WITH SEVERE PUS AND FLUID BUILD-UP AND THAT RESULTED IN TWO-STAGE REVISION DUE TO FEAR OF INFECTION WITH REIMPLANTATION IN (B)(6) 2013, BUT PERIOPERATIVE CULTURES WERE ALL NEGATIVE IN WEEKS FOLLOWING THE (B)(6) SURGERY, WITH RE-IMPLANTATION ON (B)(6) 2013. THE MDR DECISION IS BEING CHANGED TO YES FOR THE CUP AND HEAD. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458760 ASR ACETABULAR CUPS 50 HIP ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2246155

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention