BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM

    MDR report key: 12051974 · Received June 23, 2021

    Report

    Report Number
    0002249697-2021-01069
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    May 28, 2021
    Report Date
    July 23, 2021
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327287813
    PMA / PMN Number
    K172634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT AN EVENT REGARDING DISLOCATION INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS CONFIRMED BASED ON MEDICAL REVIEW. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT STATED THE FOLLOWING COMMENT: UNDATED X-RAY: RIGHT AP AND LATERAL, STEMMED TS IMPLANT, BROKEN POST OR DISLODGED METAL LOCKING POST, DISLODGED METAL WIRE, PATELLA BAHA, TIBIAL POSTERIOR SUBLUXATION. LIKELY BROKEN TIBIAL POLYETHYLENE POST OR DISLOCATED POLYETHYLENE OR BOTH, AND POSSIBLE EXTENSOR MECHANISM DISRUPTION AND KNEE INSTABILITY. X-RAY IN POSTOPERATIVE PERIOD BASED ON PRESENCE OF STAPLES. ON (B)(6) 2021: IMPLANT SHEET, ANTIBIOTIC CEMENT SIMPLEX 2 BAGS, 17X100 MM TRIATHLON STEM, TS INSERT 13MM, POST FEM AUGMENT #5 10MM AND 5MM, STEM EXTENDER 25MM X2, 18 X 100 MM TRIATHLON STEM, #% UNIVERSAL TIBIAL, #5 TS FEMUR, A35 ASYMMETRIC PATELLA. NO CHARGE ITEM 6003-003-090. CONFIRMATION: THE EVENT OF A DISLOCATED LOCKING POST AND/OR TIBIAL POLYETHYLENE IS CONFIRMED. ROOT CAUSE: THE ROOT CAUSE CANNOT BE DETERMINED WITHOUT ADDITIONAL MEDICAL RECORDS AND PERHAPS EXAMINATION OF THE IMPLANT. DURING THE POSTOPERATIVE PERIOD IT WOULD BE HIGHLY UNLIKELY THAT THERE WAS MATERIAL FAILURE. MORE LIKELY THERE WAS A SURGICAL TECHNIQUE ISSUE AS OUTLINED IN THE PI REPORT BUT THIS CANNOT BE CONFIRMED. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE ALL 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. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. THE TS INSERT WAS NOT FULLY SEATED AT IMPLANTATION, WHICH PREVENTED THE METAL POST FROM LOCKING INTO THE BASEPLATE AND SEPARATED FROM THE INSERT.THE EVENT WAS CONFIRMED BASED ON MEDICAL REVIEW.A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT STATED THE FOLLOWING COMMENT: UNDATED X-RAY: RIGHT AP AND LATERAL, STEMMED TS IMPLANT, BROKEN POST OR DISLODGED METAL LOCKING POST, DISLODGED METAL WIRE, PATELLA BAHA, TIBIAL POSTERIOR SUBLUXATION. LIKELY BROKEN TIBIAL POLYETHYLENE POST OR DISLOCATED POLYETHYLENE OR BOTH, AND POSSIBLE EXTENSOR MECHANISM DISRUPTION AND KNEE INSTABILITY. X-RAY IN POSTOPERATIVE PERIOD BASED ON PRESENCE OF STAPLES. ON (B)(6) 2021: IMPLANT SHEET, ANTIBIOTIC CEMENT SIMPLEX 2 BAGS, 17X100 MM TRIATHLON STEM, TS INSERT 13MM, POST FEM AUGMENT #5 10MM AND 5MM, STEM EXTENDER 25MM X2, 18 X 100 MM TRIATHLON STEM, #% UNIVERSAL TIBIAL, #5 TS FEMUR, A35 ASYMMETRIC PATELLA. NO CHARGE ITEM 6003-003-090. CONFIRMATION: THE EVENT OF A DISLOCATED LOCKING POST AND/OR TIBIAL POLYETHYLENE IS CONFIRMED. ROOT CAUSE: THE ROOT CAUSE CANNOT BE DETERMINED WITHOUT ADDITIONAL MEDICAL RECORDS AND PERHAPS EXAMINATION OF THE IMPLANT. DURING THE POSTOPERATIVE PERIOD IT WOULD BE HIGHLY UNLIKELY THAT THERE WAS MATERIAL FAILURE. MORE LIKELY THERE WAS A SURGICAL TECHNIQUE ISSUE AS OUTLINED IN THE PI REPORT BUT THIS CANNOT BE CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PRODUCT RETURN ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. 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

    IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. THE TS INSERT WAS NOT FULLY SEATED AT IMPLANTATION, WHICH PREVENTED THE METAL POST FROM LOCKING INTO THE BASEPLATE AND SEPARATED FROM THE INSERT. A 5X11 TS INSERT WAS REVISED TO A 5X22 TS INSERT TO ACCOMMODATE FOR THE EXTENSION MECHANISM. REP PROVIDED THE USAGE SHEET FROM THE PRIOR PROCEDURE, EXPLANT PICTURES, AND X-RAYS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. THE TS INSERT WAS NOT FULLY SEATED AT IMPLANTATION, WHICH PREVENTED THE METAL POST FROM LOCKING INTO THE BASEPLATE AND SEPARATED FROM THE INSERT. A 5X11 TS INSERT WAS REVISED TO A 5X22 TS INSERT TO ACCOMMODATE FOR THE EXTENSION MECHANISM. REP PROVIDED THE USAGE SHEET FROM THE PRIOR PROCEDURE, EXPLANT PICTURES, AND X-RAYS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944695 NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 5537-G-513-E WE8J74 07613327287813

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R