BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9898008 · Received March 30, 2020

    Report

    Report Number
    0002249697-2020-00629
    Event Type
    Injury
    Date Received
    March 30, 2020
    Date of Event
    March 2, 2020
    Report Date
    March 30, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327027235
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: TRIATHLON PS FEM COMPONENT, CEMENTED; CAT# 5515-F-502; LOT# TUIITUBP, TRIATHLON ASYMMETRIC X3 PATELLA; CAT # 5551-G-320; LOT # 1NME, TRI TS BASEPLATE SIZE 4; CAT # 5521-B-400; LOT # TZWRB, SIMPLEX P WITH TOBRAMYCIN 1 PACK; CAT # 6197-9-001; LOT # MJW074, SIMPLEX WITH TOBRAMYCIN 1 PACK; CAT # 6197-9-001; LOT # MJW074, NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM; CAT # 5537-G-416; LOT # M65DEP. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. 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

    AS REPORTED BY REP: "RIGHT KNEE EXPLANT DUE TO INFECTION." REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361539 NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 5537-G-416 M65DEP 07613327027235

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R