BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON TOTAL KNEE SYSTEM OFFSET ADAPTER 2MM

    MDR report key: 3092106 · Received May 3, 2013

    Report

    Report Number
    0002249697-2013-01508
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K070095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AFTER MULTIPLE ATTEMPTS, THE DEVICE WAS NOT LOCATED FOR RETURN. AN EVENT REGARDING AN ASSEMBLY ISSUE INVOLVING A TRIATHLON TOTAL KNEE SYSTEM OFFSET ADAPTER 2MM 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: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. -DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR REPORTED COMPLAINTS FOR THE REPORTED LOT NUMBER. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE SUBJECT DEVICE WAS NOT RETURNED FOR REVIEW. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS THE DEVICE WAS NOT RECEIVED BY STRYKER ORTHOPAEDICS. IF THE DEVICE AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. NOT RETURNED.

    Description of Event or Problem · 1

    OPENED A 2MM OFFSET ADAPTER FOR USE IN A NON-STRYKER TO STRYKER KNEE REVISION. WHEN TRYING TO ASSEMBLE THE FEMORAL IMPLANT, DOCTOR WAS UNABLE TO LOOSEN THE JAM NUT ON THE OFFSET ADAPTER. ATTEMPTED SEVERAL TIMES TO LOOSEN WITH WRENCH, BUT WAS UNABLE TO. ANOTHER 2MM OFFSET ADAPTER WAS OPENED, IT ASSEMBLED ONTO FEMORAL COMPONENT WITH NO PROBLEM.

    Description of Event or Problem · 1

    OPENED A 2MM OFFSET ADAPTER FOR USE IN A NON-STRYKER TO STRYKER KNEE REVISION. WHEN TRYING TO ASSEMBLE THE FEMORAL IMPLANT, DOCTOR WAS UNABLE TO LOOSEN THE JAM NUT ON THE OFFSET ADAPTER. ATTEMPTED SEVERAL TIMES TO LOOSEN WITH WRENCH, BUT WAS UNABLE TO. ANOTHER 2MM OFFSET ADAPTER WAS OPENED, IT ASSEMBLED ONTO FEMORAL COMPONENT WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193843 TRIATHLON TOTAL KNEE SYSTEM OFFSET ADAPTER 2MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH M3S01X

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other