BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET 360 TIBIAL AUGMENT

    MDR report key: 10362668 · Received August 4, 2020

    Report

    Report Number
    0001825034-2020-03036
    Event Type
    Injury
    Date Received
    August 4, 2020
    Date of Event
    July 16, 2020
    Report Date
    November 4, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) 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. X-RAY REVIEW INDICATES THAT LEFT TOTAL KNEE ARTHROPLASTY IS SEEN IN PLACE WITH CORTICAL THICKENING OF THE DISTAL FEMORAL DIAPHYSIS POSSIBLY INDICATING FEMORAL COMPONENT LOOSENING. NO JOINT EFFUSION. TIBIAL COMPONENT DEMONSTRATES RADIOLUCENCY AT THE BONE CEMENT INTERFACE, ALSO POSSIBLY INDICATING LOOSENING. THERE IS ALSO RADIOLUCENCY AT THE BONE CEMENT INTERFACE OF THE PATELLAR COMPONENT. OVERALL FIT AND ALIGNMENT OF THE IMPLANTS IS APPROPRIATE. OSTEOPENIA IS PRESENT DIFFUSELY. 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 PRODUCTS: VNGD SSK 360 L FEM 65MM CATALOG # 185284 LOT # 6002316. BMT SPLINED KNEE STM V2 18X80 CATALOG # 148308 LOT # 047290. BMT 360 TIB TRAY 71MM CATALOG # 185203 LOT # 747320. VG 360 DST FM AG 65X5 LL/RM CATALOG # 185324 LOT # 180890. BMT SPLINED KNEE STM V2 21X80 CATALOG # 148311 LOT # 423070. BMT 360 7.5MM OFFSET ADAPTER CATALOG # 185212 LOT # 289130. BMT 360 7.5MM OFFSET ADAPTER CATALOG # 185212 LOT # 590200. VNGD SSK PS TIB BRG 12X71/75 CATALOG # 185082 LOT # 254560. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2020-03029, 0001825034-2020-03037, 0001825034-2020-03041, 0001825034-2020-03042, 0001825034-2020-03043.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828808 BIOMET 360 TIBIAL AUGMENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 214680

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R