BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 71MM

    MDR report key: 15635539 · Received October 19, 2022

    Report

    Report Number
    0001825034-2022-02332
    Event Type
    Injury
    Date Received
    October 19, 2022
    Date of Event
    December 20, 2022
    Report Date
    March 6, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00887868247965
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 183108 - VAN PS OPEN INTL FEM-RT 65 - J6865010, VE183642 - VGD VE PS TIB BRG 71/75X12MM - 65022128, 184784 - SERIES A PAT THN 31 3 PEG - 191070, 183099 - VANGUARD FEM PEGS SET 2 - 624660. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2022-02331, 0001825034-2022-02334, 0001825034-2022-02336, 0001825034-2022-02337.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 TOTAL KNEE REPLACEMENT APPROXIMATELY ONE YEAR AGO DUE TO PAIN. THE PATIENT ALLEGES THAT THE OPERATING PHYSICIAN STATED THAT THE PATIENT'S IMPLANT HAD SHIFTED AND THE PATIENT REPORTED HAVING A SIMILAR PAIN FROM THEIR LEG TO THEIR ANKLE AND DOWN THEIR LEG AS THEY DID PRIOR TO THE SURGERY. THE PATIENT FURTHER ALLEGED THAT THEIR NEW SURGEON ADVISED THAT THE IMPLANT WAS TOO LARGE AND WOULD NEED TO BE REVISED. THE PATIENT IS SCHEDULED FOR A REVISION SURGERY; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT A REVISION KNEE SURGERY APPROXIMATELY 14 MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    2047090 BIOMET CC CRUCIATE TRAY 71MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J7018320 00887868247965

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other SEE H10.