BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARTIAL ARTICULAR SURFACE

    MDR report key: 16775845 · Received April 20, 2023

    Report

    Report Number
    0001825034-2023-00863
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    June 27, 2022
    Report Date
    April 20, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSX
    UDI-DI
    00880304818187
    PMA / PMN Number
    K161592
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCT: PARTIAL TIBIAL CEMENTED SIZE E LEFT MEDIAL CATALOG # 42538000501 LOT # 65286273 TWO (2) DEVICE IDS WERE PROVIDED BY THE CUSTOMER/REPORTER; OF THESE, ONLY ONE (1) WAS REPORTED NOT TO SEAT WITH MATING WITH DEVICE. IT IS UNKNOWN WHICH EXACT DEVICE ENCOUNTERED THIS ISSUE, IT IS ONE OF THE FOLLOWING: ITEM#: 42518200509, LOT#: 65260716; ITEM NAME: PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE E 9 MM THICKNESS MANUFACTURE DATE: JAN 13, 2022 STERILE EXPIRY DATE: DEC 12, 2026 UDI: (B)(4). 510K: K161592, PRO CODE: HSX. OR ITEM#: 42518200510, LOT#: 64214804, SERIAL#: PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE E 10 MM THICKNESS MANUFACTURE DATE: NOV 9, 2018 STERILE EXPIRY DATE: OCT 31, 2023 UDI: (B)(4). 510K: K161592, PRO CODE: HSX. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE WAS NOT SEATING WITH MATING DEVICE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157474 PARTIAL ARTICULAR SURFACE PROSTHESIS KNEE HSX ZIMMER BIOMET, INC. N/A 65260716 00880304818187

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown