BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 47

    MDR report key: 1903359 · Received November 16, 2010

    Report

    Report Number
    1818910-2010-07864
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 17, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KXA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THIS IMPLANT IS NOT SOLD IN THE US TO BE IMPLANTED FOR THIS INDICATION; IT WOULD BE SOLD UNDER A DIFFERENT PART NUMBER AS IT IS INDICATED ONLY TO BE USED AS A HEMI IN THE US AT THIS TIME.

    Additional Manufacturer Narrative · 1

    JOHNSON AND JOHNSON MEDICAL (B)(4) REPORTS: ON (B)(6) 2005, DR (B)(6) PERFORMED A RESURFACING LEFT HIP ON THIS PATIENT AT THE SAN. PATIENT PRESENTED TO HIS ROOMS RECENTLY WITH INCREASING PAIN. REVISION SURGERY WAS PERFORMED ON (B)(6) 2010. OBSERVATION DURING REVISION SURGERY, THE JOINT WAS DRY, METAL STAINING IN TISSUES. NECROTIC TISSUE IN PSOAS SHEATH. OSTEOLYSIS ALSO EVIDENT. ASR CUP REMOVED USING ZIMMER EXPLANTS SYSTEM. REPLACED WITH PINNACLE GRIPTION SECTOR CUP AND FEMORAL NECK REMOVED, REPLACED WITH CORAIL SIZE 12 STEM. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. ALTHOUGH THE ROOT CAUSE CANNOT BE DETERMINED, IT IS KNOWN THAT THE ASR PLATFORM WAS VOLUNTARILY RECALLED IN AUGUST OF 2010 FOLLOWING AN HHE (HEALTH HAZARD EVALUATION). FURTHER ANALYSIS REGARDING THE ASR PRODUCT FAMILY WILL BE DOCUMENTED, AS DETERMINED PERTINENT, IN (B)(4) AND (B)(4). BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR FURTHER CORRECTIVE ACTION IS NOT INDICATED AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS PAIN, NECROTIC TISSUE, AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR FEM IMP SIZE 47 THA KXA DEPUY INTERNATIONAL, LTD. NA 1177843

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention