BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTPILLAR 64 ELI SIZE 4 RIGHT

    MDR report key: 4825283 · Received June 8, 2015

    Report

    Report Number
    0002249697-2015-01816
    Event Type
    Injury
    Date Received
    June 8, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 11, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CATALOG NUMBER, LOT CODE, MANUFACTURE AND EXPIRATION DATES WERE CORRECTED. AN EVENT REGARDING LOOSENING INVOLVING A CENTPILLAR STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR CLINICAL EVALUATION. DEVICE HISTORY REVIEW: DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE. CONCLUSIONS: THE EXACT CAUSE OF THIS EVENT COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. FURTHER INFORMATION SUCH AS DEVICE ANALYSIS, ADDITIONAL X-RAYS AND OPERATIVES REPORT ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THA FOR OA ON (B)(6) 2007. EIGHT YEARS AFTER THE PRIMARY OPERATION, THE STEM LOOSENED. ON (B)(6) 2015, THE STEM WAS REPLACED. CUP WAS NOT LOOSENED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THA FOR OA ON (B)(6) 2007. 8 YEARS AFTER THE PRIMARY OPERATION, THE STEM LOOSENED. ON (B)(6) 2015, THE STEM WAS REPLACED. CUP WAS NOT LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369086 CENTPILLAR 64 ELI SIZE 4 RIGHT HIP IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 17858801

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R