BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAN PS OPEN INTL FEM-RT 67.5

    MDR report key: 18261121 · Received December 4, 2023

    Report

    Report Number
    0001825034-2023-02859
    Event Type
    Injury
    Date Received
    December 4, 2023
    Report Date
    December 27, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    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

    (B)(4). D10: 141213 - BIOMET ILOK PRI TIB TRAY 71MM - 863040; 141318 - BIOMET FINNED PRI STM 80X12.5 - 455540; 183740 - VNGD PS+ TIB BRG 10X71/75MM - 101280; 11-150842 - BMET ARCOM AP PAT 3PST 34MM MD - 165150; UNKNOWN - UNKNOWN CEMENT - UNKNOWN. 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: 0001825034-2023-02860, 0001825034-2023-02861, 0001825034-2023-02862, 0001825034-2023-02863.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6 : MECHANICAL (G04) - FEMUR. 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. PRIMARY OPERATIVE NOTES STATE NO INTRA OPERATIVE COMPLICATIONS. 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 RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS HAD ONGOING TREATMENT AND THERAPY AND NOTED THE POSSIBILITY OF A REVISION. NO FURTHER OUTCOMES OR REVISIONS HAVE BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE 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
    2178280 VAN PS OPEN INTL FEM-RT 67.5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 020610

    Patients

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