BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENT CON TIB BRG 18X71/75

    MDR report key: 18359947 · Received December 19, 2023

    Report

    Report Number
    0001825034-2023-03013
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    November 30, 2023
    Report Date
    April 17, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K982869
    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

    (B)(4). D10: UNKNOWN - UNKNOWN PATELLA - UNKNOWN 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: 0001825034-2023-03014

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PHOTOGRAPH IDENTIFIED AN EXPLANTED ARTICULAR SURFACE WITH WEAR. THE PICTURES WERE INSUFFICIENT TO COMPLETE A DIMENSIONAL EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. THE PROVIDED RADIOGRAPHS WERE NOT REVIEWED AS THEY ARE UNDATED AND NOT CONSECUTIVE TO BE ABLE TO ASSES FOR IMPLANT WEAR. 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 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.

    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
    2049562 ASCENT CON TIB BRG 18X71/75 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 204820

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization| R SEE H10.