BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING

    MDR report key: 18790375 · Received February 27, 2024

    Report

    Report Number
    0001822565-2024-00656
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    February 5, 2024
    Report Date
    June 28, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K173417
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE . REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THAT THE EXPLANTED TIBIAL PLATE WITH FOREIGN MATERIAL ON IT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: HEADLESS TROCAR DRILL PIN 75MM CATALOG # 00-5901-020-00 LOT # 66195669 2.5 MM FEMALE HEX SCREW 25 MM LENGTH CATALOG # 42509902525 LOT # 65652163 TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE F CATALOG # 42532007502 LOT # 65968349 PSN TPR ST 14 X +30 MM CATALOG # 42-5570-001-14 LOT # 66328274 TM TIBIAL CENTRAL CONE SZ SM CATALOG # 42-5450-005-11 LOT # 66121728 PSN MC VE ASF R 14MM 8-11/EF CATALOG # 42-5221-008-14 LOT # 65560810 PSN FEM CR POR CCR NRW SZ 10 R CATALOG # 42-5022-068-02 LOT # 64639780 PSN ASF UC 10MM VE R 4-11 EF CATALOG # 42-5222-005-10 LOT # 64966432 NEXGEN POROUS PATELLA 10M CATALOG # 00-5878-065-35 LOT # 65129912 H3: PRODUCT HAS NOT BEEN RETURNED TO ZIMMER BIOMET. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWO YEARS POST IMPLANTATION DUE TO TIBIAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102975 TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING PROSTHESIS KNEE MBH ZIMMER BIOMET, INC. N/A 65085895

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H10 NARRATIVE