BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM

    MDR report key: 4123292 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03627
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    May 6, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K072221
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT LINER EXCHANGE FOLLOWING TKA REVISION WHICH OCCURRED ON (B)(6) 2014 FOR MECHANICAL LOOSENING.

    Description of Event or Problem · 1

    POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT LINER EXCHANGE FOLLOWING TKA REVISION WHICH OCCURRED ON (B)(6) 2014 FOR MECHANICAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602730 NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MLRRNA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention