BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ILOK STEM TIB TRAY 67MM

    MDR report key: 18266131 · Received December 5, 2023

    Report

    Report Number
    0001825034-2023-02869
    Event Type
    Injury
    Date Received
    December 5, 2023
    Report Date
    May 7, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. 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 PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING NO COMPLICATION DURING INITIAL SURGERY, NO OTHER INFORMATION WAS 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 183324 - VNGD SSK INTLK FMRL 65 LT - 415790, 141624 - BMT SPLINED KNEE STM 24X80 - 517450, 141618 - BMT SPLINED KNEE STM 18X80 - 234140, 183862 - VNGD SSK PSC TIB BRG 12X63/67 - 324770, 11-150842 - BMET ARCOM AP PAT 3PST 34MM MD - 171810, 184244 - VNGD POST FEM AUG 65X10 LL/RM - 051700, 184144 - VNGD POST FEM AUG 65X5 RL/LM - 026050, 141742 - BIOMET TIB BLOCK 6MM 67 - 221870, 141742 - BIOMET TIB BLOCK 6MM 67 - 430830, 402283 - COBALT G-HV BONE CEMENT 40G - 161120, 402283 - COBALT G-HV BONE CEMENT 40G - 853920. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-02868, 0001825034-2023-02870, 0001825034-2023-02871, 0001825034-2023-02872, 0001825034-2023-02873, 0001825034-2023-02874, 0001825034-2023-02875, 0001825034-2023-02876, 0001825034-2023-02877.

    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 THAT THE PATIENT UNDERWENT A LEFT KNEE SURGERY. SUBSEQUENTLY, THE PATIENT HAS HAD ONGOING TREATMENT AND THERAPY AND NOTED THE POSSIBILITY OF A REVISION. NO FURTHER INFORMATION OR OUTCOME HAS BEEN PROVIDED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049127 BIOMET ILOK STEM TIB TRAY 67MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 785160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H10.