BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PAT THN 34 3 PEG

    MDR report key: 14986858 · Received July 12, 2022

    Report

    Report Number
    0001825034-2022-01598
    Event Type
    Injury
    Date Received
    July 12, 2022
    Date of Event
    June 16, 2022
    Report Date
    November 10, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304436749
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01592, 0001825034-2022-01593, 0001825034-2022-01594, 0001825034-2022-01595, 0001825034-2022-01596, 0001825034-2022-01597. MEDICAL DEVICES: BMT 360 TIB AUG 67X10MM CATALOG#: 185232 LOT#: 491370; BMT 360 TIB AUG 67X10MM CATALOG#: 185232 LOT#: 622080; BMT 360 TIB LG CRUCIATE WING CATALOG#: 185651 LOT#: 160950; BMT SPLINED KNEE STM V2 18X80 CATALOG#: 148308 LOT#: 710510; BMT 360 TIB TRAY 67MM CATALOG#: 185202 LOT#: 718090; VNGD SSK PS TIB BRG 18X63/67 CATALOG#: 185068 LOT#: 845430. FOREIGN SOURCE: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01592, 0001825034-2022-01593, 0001825034-2022-01594, 0001825034-2022-01595, 0001825034-2022-01596, 0001825034-2022-01597, 0001825034-2022-01598, AND 0001825034-2022-01917. MEDICAL DEVICES: BMT 360 TIB AUG 71X10MM CATALOG#: 185233 LOT#: 970810. BMT 360 TIB AUG 71X10MM CATALOG#: 185233 LOT#: 956120. BMT 360 TIB LG CRUCIATE WING CATALOG#: 185651 LOT#: 805380. BMT SPLINED KNEE STM V2 18X40 CATALOG#: 148293 LOT#: 998960. BMT 360 TIB TRAY 71MM CATALOG#: 185203 LOT#: 502940. VNGD SSK PSC TIB BRG 14X71/75 CATALOG#: 183884 LOT#: 820100. VNGD SSK 360 FEMUR L 67.5 CATALOG#: 185285 LOT#: 6668552. BMT 360 2.5MM OFFSET ADAPTER CATALOG#: 185210 LOT#: 136930. BMT SPLINED KNEE STM V2 18X40 CATALOG#: 148293 LOT#: 998960. BMT 360 2.5MM OFFSET ADAPTER CATALOG#: 185210 LOT#: 057070.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, G3, G6, H2, H3, H6, AND H10. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY TWENTY-TWO MONTHS POST IMPLANTATION DUE TO PAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY TWENTY-TWO MONTHS POST IMPLANTATION DUE TO PAIN.

    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
    772330 SERIES A PAT THN 34 3 PEG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 512610 00880304436749

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H