BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES I TIBIAL BEARING INSERT

    MDR report key: 3910771 · Received July 2, 2014

    Report

    Report Number
    0002249697-2014-02527
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HSX
    PMA / PMN Number
    K862837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING JOINT INSTABILITY INVOLVING A SCORPIO INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A VISUAL INSPECTION FOUND NO MATERIAL OR MANUFACTURING DEFECTS. A VISUAL INSPECTION SHOWED EVIDENCE OF DELAMINATION AND PITTING. THESE ARE FATIGUE WEAR MECHANISMS ARE CONSISTENT WITH COMMONLY IDENTIFIED DAMAGE MODES IN UHMWPE INSERTS. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO PATIENT INFORMATION WAS PROVIDED FOR REVIEW. -DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO SIMILAR PREVIOUS REPORTED EVENTS FOR THIS LOT ID. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT PATIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERT WHICH WAS IMPLANTED FOR LEFT KNEE AND REPLACED 12 YEARS AFTER IMPLANTED. THE IMPLANT WAS IMPLANTED IN (B)(6) 1993. SOFT TISSUE LOOSENING WAS CONFIRMED, SO IT (8MM) WAS CHANGED TO 15MM INSERT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERT WHICH WAS IMPLANTED FOR LEFT KNEE AND REPLACED 12 YEARS AFTER IMPLANTED. THE IMPLANT WAS IMPLANTED IN (B)(6)1993. SOFT TISSUE LOOSENING WAS CONFIRMED, SO IT (8MM) WAS CHANGED TO 15MM INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386284 SERIES I TIBIAL BEARING INSERT IMPLANT HSX STRYKER ORTHOPAEDICS-MAHWAH AYBF

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R