BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR TAP SLV ADAP 12/14 -1

    MDR report key: 3120598 · Received May 20, 2013

    Report

    Report Number
    1818910-2013-06824
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 23, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K070359
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE WARSAW AND INTERNATIONAL COMPLAINTS DATABASES FINDS ONE OTHER REPORT AGAINST THE FEMORAL STEM PRODUCT AND LOT CODE COMBINATION SINCE RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. IT IS KNOWN 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. REF. (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

    LITIGATION ALLEGES PATIENT HAD PAIN AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT AFTER ASR HIP IMPLANT. DOI: (B)(6) 2008 (RIGHT HIP). DOR: NONE REPORTED (SCHEDULED FOR (B)(6) 2013). PATIENT IS RESIDENT OF (B)(6). **UPDATE**(B)(6) 2013-SALES REP REPORTED REVISION SURGERY DUE TO UNKNOWN REASONS ON (B)(6) 2013. DOR: (B)(6) 2013. **UPDATE** ((B)(6) 2013) - PATIENT FACT SHEET WAS RECEIVED. THE PART/LOT NUMBERS HAVE BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. **UPDATE** (B)(6) 2013 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION EFFUSION OF FLUID UNDER PRESSURE, SIGNIFICANT CAPSULAR CHANGES WITH THICKENED HARDENED CAPSULE, LOOSE NECROTIC DEBRIS IN THE JOINT SPACE, ACETABULAR COMPONENT WITH NO BONE INGROWTH, AND THE TRUNNION WITH HEAVY CORROSION WERE ALL FOUND IN THE HIP JOINT. THE STEM AND SLEEVE WERE ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222002 ASR TAP SLV ADAP 12/14 -1 SLEEVE KWA DEPUY INTERNATIONAL 2543063

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention