BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT SPLINED KNEE STM

    MDR report key: 17405035 · Received July 27, 2023

    Report

    Report Number
    0001825034-2023-01757
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    June 29, 2023
    Report Date
    November 21, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OIY
    UDI-DI
    00880304001350
    PMA / PMN Number
    K915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: SERIES A PAT STD 34 3 PEG CATALOG # 184766 LOT # 027070. BMT SPLINED KNEE STM 18X80 CATALOG # 141618 LOT # 772440. OFFSET TIB TRAY 5.0MM ADAPTOR CATALOG # 141491 LOT # 591140. VNGD SSK INTLK FMRL 70 LT CATALOG # 183326 LOT # 050040. BIOMET OFFSET TIBIAL TRAY 75MM CATALOG # 141484 LOT # 077120. VNGD SSK PS TIB BRG 12X71/75 CATALOG # 185082 LOT # 071370. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6: MECHANICAL (G04) - STEM. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. MEDICAL RECORDS REVIEW INDICATES THAT PATIENT NOTED GRINDING AND THE KNEE WAS BUCKLING. SCREW WAS FOUND TO BE BACKED OUT IN X-RAYS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT IS EXPERIENCING INSTABILITY AND NOISE IN KNEE SIX MONTHS POST IMPLANTATION. RADIOGRAPH NOTED THE SCREW WAS FOUND TO HAVE BACKED OUT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817450 BMT SPLINED KNEE STM PROSTHESIS KNEE OIY ZIMMER BIOMET, INC. N/A 522250 00880304001350

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other