BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-TAPER COCR LFIT HEAD 32MM/-5

    MDR report key: 5683074 · Received May 26, 2016

    Report

    Report Number
    0002249697-2016-01742
    Event Type
    Injury
    Date Received
    May 26, 2016
    Date of Event
    May 2, 2016
    Report Date
    May 2, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LWJ
    PMA / PMN Number
    K993601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION INVOLVING AN METAL HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. DEVICE HISTORY REVIEW: DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER EVENT FOR THE LOT REFERENCED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    REVISION OF LINER. SALES REP REPORTING WAS NOT PRESENT FOR THE CASE. PRODUCTS EXPLANTED IS 06-3299 LOT: 20027101 AND A LINER. THE LINER (32MM LINER FOR A 54MM CUP) WAS DESTROYED BEYOND RECOGNITION.

    Description of Event or Problem · 1

    REVISION OF LINER. SALES REP REPORTING WAS NOT PRESENT FOR THE CASE. PRODUCTS EXPLANTED IS 06-3299 LOT: 20027101 AND A LINER. THE LINER (32MM LINER FOR A 54MM CUP) WAS DESTROYED BEYOND RECOGNITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335511 C-TAPER COCR LFIT HEAD 32MM/-5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED LWJ STRYKER ORTHOPAEDICS-MAHWAH 20027101

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention