BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM

    MDR report key: 17654128 · Received August 30, 2023

    Report

    Report Number
    0002249697-2023-00974
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    August 7, 2023
    Report Date
    November 4, 2023
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327287745
    PMA / PMN Number
    K172634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING DISLOCATION INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS CONFIRMED VIA CLINICIAN REVIEW OF THE PROVIDED MEDICAL RECORDS. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT STATED THE FOLLOWING COMMENTS: THIS PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY USING A TS CONSTRAINED IMPLANT. A DISLOCATION OCCURRED. A REVISION PROCEDURE WAS CARRIED OUT APPROXIMATELY TWO MONTHS FOLLOWING IMPLANTATION. I CAN CONFIRM THAT THE PATIENT HAD THE TS TOTAL KNEE ARTHROPLASTY SINCE I WAS ABLE TO REVIEW THE X-RAY. I CAN CONFIRM THE DISLOCATION SINCE THAT WAS PRESENT ON THE X-RAY. I CANNOT CONFIRM THE REVISION SINCE I HAVE NO DOCUMENTATION SUCH AS OFFICE NOTES, OPERATION REPORT OR POST REVISION X-RAYS. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. THE CAUSES OF POSTERIOR DISLOCATION, TWO MONTHS FOLLOWING IMPLANTATION ARE MULTIFACTORIAL. SURGICAL TECHNIQUE FACTORS PLAY A SIGNIFICANT ROLE. POSTERIOR DISLOCATION USUALLY OCCURS WHEN THE FLEXION GAP IS LARGER THAN THE EXTENSION GAP. OTHER FACTORS INCLUDE PATIENT ACTIVITY LEVEL AND BMI. I WOULD NOT ASSIGN ANY CAUSALITY TO THE IMPLANT ITSELF. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSION: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT STATED THE FOLLOWING COMMENTS: THIS PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY USING A TS CONSTRAINED IMPLANT. A DISLOCATION OCCURRED. A REVISION PROCEDURE WAS CARRIED OUT APPROXIMATELY TWO MONTHS FOLLOWING IMPLANTATION. I CAN CONFIRM THAT THE PATIENT HAD THE TS TOTAL KNEE ARTHROPLASTY SINCE I WAS ABLE TO REVIEW THE X-RAY. I CAN CONFIRM THE DISLOCATION SINCE THAT WAS PRESENT ON THE X-RAY. I CANNOT CONFIRM THE REVISION SINCE I HAVE NO DOCUMENTATION SUCH AS OFFICE NOTES, OPERATION REPORT OR POST REVISION X-RAYS. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. THE CAUSES OF POSTERIOR DISLOCATION, TWO MONTHS FOLLOWING IMPLANTATION ARE MULTIFACTORIAL. SURGICAL TECHNIQUE FACTORS PLAY A SIGNIFICANT ROLE. POSTERIOR DISLOCATION USUALLY OCCURS WHEN THE FLEXION GAP IS LARGER THAN THE EXTENSION GAP. OTHER FACTORS INCLUDE PATIENT ACTIVITY LEVEL AND BMI. I WOULD NOT ASSIGN ANY CAUSALITY TO THE IMPLANT ITSELF. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED: REVISION OF A LTK DUE TO DISLOCATION.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED: REVISION OF A LTK DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397135 NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH R64XL2 07613327287745

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Required Intervention| H