BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS RS 14MM LS TIBIAL BEARING

    MDR report key: 17614129 · Received August 24, 2023

    Report

    Report Number
    0001825034-2023-01979
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    August 10, 2023
    Report Date
    August 22, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304481138
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 161034 - OSS RS POLY FEM BUSHINGS SET/2 - (B)(6). 150510 - OSS POLY BUMPER LOCK PIN - (B)(6). 150493 - OSS REINFORCED YOKE - (B)(6). 150481 - DIAH SEG LOCK SCREW SET - (B)(6). 150476 - OSS POLY TIBIAL BUSHING - (B)(6). G2: FOREIGN COUNTRY: JAPAN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS APPROXIMATELY 2.5 YEARS LATER. ONLY THE POLY WAS REVISED AND THE SURGEON NOTED THAT THE PATIENT REQUESTED THE REVISION AND THAT THERE WAS NO MAJOR DAMAGE TO THE BEARING. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2114747 OSS RS 14MM LS TIBIAL BEARING PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 887190 00880304481138

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10.