BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HMRS BEARING - 18 X 24

    MDR report key: 3012664 · Received March 20, 2013

    Report

    Report Number
    0002249697-2013-01046
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    January 16, 2013
    Report Date
    March 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING WEAR/DELAMINATION OF A BUSHING INVOLVING AN HMRS FIXED HINGED KNEE BUSHING WAS REPORTED. THE EVENT WAS CONFIRMED. THE BUSHING FAILED THROUGH DELAMINATION WHICH IS A WEAR FAILURE MODE. NO MANUFACTURING OR MATERIAL DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. MEDICAL EVALUATION CONCLUDED: "MECHANICAL FAILURE AFTER FIFTEEN YEARS IN SITU OF A MAJOR SALVAGE SURGERY IN A YOUNG PATIENT IS NOT UNEXPECTED AND NOT THE RESULT OF MANUFACTURING OR MATERIAL DEFECTS." THE INVESTIGATION CONCLUDED THAT MECHANICAL FAILURE OF THE HMRS BUSHING WAS CAUSED BY USER RELATED FACTORS IN THAT THE REPORTED DEVICE HAD BEEN IMPLANTED FOR APPROXIMATELY 15 YEARS IN A YOUNG PATIENT WHO HAD A MAJOR SALVAGE SURGERY AND WHICH IS NOT UNEXPECTED. MATERIAL ANALYSIS INDICATED THAT THE BUSHING FAILED THROUGH WEAR, I.E. DELAMINATION AND DID NOT IDENTIFY MANUFACTURING OR MATERIAL DEFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S KNEE LOOKED VALGUS IN THE X-RAY AFTER REPLACEMENT OF HMRS PROXIMAL TIBIA. THE SURGEON SUSPECTED ABLATION OF THE BEARING BUSH AND PERFORMED REVISION ON (B)(6) 2013. BREAKAGE AND ABLATION OF THE BUSHING WERE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S KNEE LOOKED VALGUS IN THE X-RAY AFTER REPLACEMENT OF HMRS PROXIMAL TIBIA. THE SURGEON SUSPECTED ABLATION OF THE BEARING BUSH AND PERFORMED REVISION ON (B)(6) 2013. BREAKAGE AND ABLATION OF THE BUSHING WERE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116619 HMRS BEARING - 18 X 24 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention