BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VG 360 DST FM AG 67.5X5 RL/LM

    MDR report key: 7885095 · Received September 18, 2018

    Report

    Report Number
    0001825034-2018-08968
    Event Type
    Injury
    Date Received
    September 18, 2018
    Report Date
    July 9, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. X-RAY EVALUATION BY A THIRD PARTY HEALTH CARE PRACTITIONER STATES THAT THERE IS LIMITED EVALUATION OF A LEFT TOTAL KNEE ARTHROPLASTY, WITH NO HARDWARE FAILURE OR LOOSENING, AND NO FRACTURE NOTED. ROOT CAUSE WAS UNABLE TO 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: VNGD SSK PS TIB BRG 10X71/75 CATALOG#: 185080 LOT#: 034860, BMT 360 2.5 MM OFFSET ADAPTER CATALOG#: 185210 LOT#: 759770, BMT 360 TIB SM CRUCIATE WING CATALOG#: 185650 LOT#: 725770, BMT 360 TIB TRAY 71 MM CATALOG#: 185203 LOT#: 937920, BMT 360 TIB AUG 71 X 10 MM CATALOG#: 185233 LOT#: 602330, VG 360 UNIV PST FM AUG 67.5X5 CATALOG#: 185345 LOT#: 190200, VNGD SSK 360 FEMUR L 67.5 CATALOG#: 185285 LOT#: 3357685, BMT SPLINED KNEE STM V2 17X40 CATALOG#: 148292 LOT#: 979960, VG 360 DST FM AG 67.5X15 LL/RM CATALOG#: 185485 LOT#: 761910, BMT 360 TIB AUG 71X10 MM CATALOG#: 185233 LOT#: 115500, BMT SPLINED KNEE STM V2 18X120 CATALOG#: 148321 LOT#: 070920, VG 360 DST FM AG 67.5X5 LL/RM CATALOG#: 185325 LOT#: 577550. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08957, 0001825034-2018-08958, 0001825034-2018-08959, 0001825034-2018-08960, 0001825034-2018-08961, 0001825034-2018-08963, 0001825034-2018-08964, 0001825034-2018-08965, 0001825034-2018-08966, 0001825034-2018-08967, 0001825034-2018-08969, AND 0001825034-2018-08970. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION LEFT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN, WHICH HAS BEEN LIMITING THE PATIENTS ACTIVITIES. NO FURTHER REVISION PROCEDURE HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726732 VG 360 DST FM AG 67.5X5 RL/LM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 661740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other