BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PATELLA

    MDR report key: 18359958 · Received December 19, 2023

    Report

    Report Number
    0001825034-2023-03014
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    November 30, 2023
    Report Date
    January 17, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS NO ALLEGATIONS WERE MADE AGAINST THE DEVICE. 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: 179274 - ASCENT CON TIB BRG 18X71/75 - 204820. 178054 - ASCENT CLSD BOX PS FMRL LG L - 541710. 141484 - BIOMET OFFSET TIBIAL TRAY 75MM - 778140. 179075 - ASCENT REV FEM STEM 20X150 - 727740. 141490 - OFFSET TIB TRAY 2.5MM ADAPTOR - 393460. 141616 - BMT SPLINED KNEE STM 16X80 - 10880. 3015-040 - CMW 1 GENTAMICIN CEMENT - 2064421. 3015-040 - CMW 1 GENTAMICIN CEMENT -2064421. G2 : FOREIGN COUNTRY : AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. 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: 0001825034-2023-03013.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE PATELLA WAS REVISED DUE TO STANDARD PRACTICE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE AND APPROXIMATELY 16 YEARS LATER, WAS REVISED DUE TO INSTABILITY AND POLY WEAR. PATELLA WEAR AND DELAMINATION WERE SEEN FROM THE PROVIDED IMAGES. THE BEARING AND PATELLA WERE EXCHANGED BY THE SURGEON. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049946 UNKNOWN PATELLA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R