BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM

    MDR report key: 4863989 · Received June 23, 2015

    Report

    Report Number
    0002249697-2015-02048
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 1, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS SENT TO PATHOLOGY AS PER OR PROTOCOL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT INVOLVING THE REVISION OF A TRIATHLON TS 19MM INSERT TO A THICKER INSERT TO A DUE TO INSTABILITY LEADING TO POSTERIOR DISLOCATION WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: CLINICIAN REVIEW OF THE MEDICAL RECORDS PROVIDED INDICATED THAT MULTIPLE REVISION SURGERIES HAVE CAUSED KNEE LIGAMENT SCAR TISSUE FORMATION CONTRIBUTING TO LATE INSTABILITY OF THE KNEE THROUGH GRADUAL SCAR TISSUE RELAXATION REQUIRING LINER EXCHANGE FOR A THICKER ONE. DEVICE HISTORY REVIEW: INDICATED THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: INDICATED THAT THERE HAVE BEEN NO OTHER SIMILAR REPORTED EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: CLINICIAN REVIEW OF THE MEDICAL RECORDS PROVIDED INDICATED THAT MULTIPLE REVISION SURGERIES HAVE CAUSED KNEE LIGAMENT SCAR TISSUE FORMATION CONTRIBUTING TO LATE INSTABILITY OF THE KNEE THROUGH GRADUAL SCAR TISSUE RELAXATION REQUIRING LINER EXCHANGE FOR A THICKER ONE. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INSTABILITY MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    DR. REPORTS PATIENT, A STATUS POST RIGHT KNEE REVISION BACK ON (B)(6) 2014, HAS POSTERIORLY DISLOCATED AND DR. WOULD LIKE TO CHANGE THE INSERT TO A THICKER ONE. DR. (B)(6) PROCEEDED TO REVISE THE INSERT.

    Description of Event or Problem · 1

    DR. REPORTS PATIENT, A STATUS POST RIGHT KNEE REVISION BACK ON (B)(6) 2014, HAS POSTERIORLY DISLOCATED AND DR. WOULD LIKE TO CHANGE THE INSERT TO A THICKER ONE. DR. (B)(6) PROCEEDED TO REVISE THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405386 NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH MNNR77

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention