BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASR TAP SLV ADAP 12/14 -1

    MDR report key: 3012315 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-04356
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    October 20, 2011
    Report Date
    February 18, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K070359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE 3L92512/5008861 PRODUCT/LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. ADDITIONALLY, RESEARCH USING THE AS400 SYSTEM INDICATES THAT SEVERAL OTHER DEVICES FROM THE REPORTED LOT HAVE BEEN DELIVERED AND ARE CONSIDERED SUCCESSFULLY IMPLANTED AS NO OTHER REPORTS HAVE BEEN RECEIVED. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED REGARDING THE REPORTED CORROSION. HOWEVER, IT WAS STATED IN THE PROVIDED MEDICAL RECORDS, THE CORROSION WAS CLEANED. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR FURTHER CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT. ON (B)(4) 2011 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED DUE TO PAIN AND OSTEOLYSIS. ON (B)(4) 2013 - PATIENTS OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION THERE WAS NO EVIDENCE OF OSTEOLYSIS FOUND. RECORDS ALSO INDICATE THAT HEAVY CORROSION ON THE TRUNNION WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115134 ASR TAP SLV ADAP 12/14 -1 SLEEVE KWA DEPUY INTERNATIONAL 2837697

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR