BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARTIAL ARTICULAR SURFACE

    MDR report key: 15093785 · Received July 25, 2022

    Report

    Report Number
    0001822565-2022-02181
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    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: (B)(6) 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: (B)(6) 2018. STERILE EXPIRY DATE: OCT 31, 2023. UDI: (B)(4). 510K: K161592, PRO CODE: HSX. DEVICE EVALUATED BY MFR: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, THE INITIAL REPORT WAS SUBMITTED UNDER INCORRECT MANUFACTURING SITE. THIS REPORT WILL BE COMPLETED UNDER MANUFACTURING REPORT NUMBER 0001825034-2023-00863.

    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 AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, THE INITIAL REPORT WAS SUBMITTED UNDER INCORRECT MANUFACTURING SITE. THIS REPORT WILL BE COMPLETED UNDER MANUFACTURING REPORT NUMBER 0001825034-2023-00863

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570529 PARTIAL ARTICULAR SURFACE PROSTHESIS KNEE HSX ZIMMER BIOMET, INC. N/A 65260716 00880304818187

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10 NARRATIVE