BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR TAP SLV ADAP 12/14 -1

    MDR report key: 2971571 · Received February 21, 2013

    Report

    Report Number
    1818910-2013-03907
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    July 30, 2012
    Report Date
    January 22, 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
    TX, US
    Reporter Occupation
    OTHER

    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS OF ANY KIND AGAINST THE C38D31 LOT CODE. 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. IT IS KNOWN THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE PERFORMED INVESTIGATION AND LACK OF PRODUCT TO EXAMINE, THE NEED FOR FURTHER CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. 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 PAIN. UPDATE: LITIGATION PAPERS ALLEGES, THE PATIENT SUFFERED FROM PROGRESSIVELY INCREASING LEFT HIP PAIN ESPECIALLY WHEN HE WALKED, AMBULATED WITH A LIMP, AND LEFT HIP HAD CLICKING, CATCHING AND POPPING WHICH CAUSED TROCHANTERIC AND GROIN PAIN. PATIENT HAD HEADACHES AND HE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT. HE SUFFERED FROM STIFFNESS IN HIS HIP AND FEELINGS OF TIGHTNESS AND INFLAMMATION WHICH HAD WORSENED OVER THE LAST FEW MONTHS PRIOR TO HIS REVISION SURGERY. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: ((B)(6) 2012) - PATIENT FACT SHEET WAS RECEIVED. THE DOI HAS BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: ((B)(6) 2012) - 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: 01/22/2013 - MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATES THE TRUNNION HAD TYPICAL HOLE BLACK DEBRIS PRESENT FROM CORROSIVE REACTION ON THE TAPER AND INCREASING METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76729 ASR TAP SLV ADAP 12/14 -1 SLEEVE KWA DEPUY INTERNATIONAL 2837696

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention