BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET 360 TIBIAL TRAY WITH LOCKING BAR AND SCREW

    MDR report key: 6960924 · Received October 19, 2017

    Report

    Report Number
    0001825034-2017-08820
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    September 20, 2017
    Report Date
    October 24, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN VANGUARD FEMUR; NON-CONSTRAINED VANGUARD DCM TIBIAL BEARING. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 185060, VNGD SSK PS TIB BRG 10X63/67, LOT # 275900. CATALOG #: 185287, VNGD SSK 360 FEMUR L 72.5, LOT # 2949489. CATALOG #: 148319, BMT SPLINED KNEE STM V2 16X120, LOT # 682750. CATALOG #: 148317, BMT SPLINED KNEE STM V2 14X120, LOT # 229130. CATALOG #: 185232, BMT 360 TIB AUG 67X10MM, LOT # 751450. CATALOG #: 185347, VG 360 UNIV PST FM AUG 72.5X5, LOT # 088950. CATALOG #: 185407, VG 360 DST FM AG 72.5X10 LL/RM, LOT # 062030. CATALOG #: 185387, VG 360 DST FM AG 72.5X10 RL/LM, LOT # 002200. CATALOG #: 185346, VG 360 UNIV PST FM AUG 70X5, LOT # 362020. CATALOG #: 185231, BMT 360 TIB AUG 63X10MM, LOT # 576930. REPORTED EVENT WAS CONFIRMED DUE TO X-RAYS SHOWING A FRACTURED LOCKING BAR. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. PROVIDED X-RAYS WERE REVIEWED AND NOTED LEFT TOTAL KNEE ARTHOPLASTY WITH APPARENT FRACTURED LOCKING BAR EXTENDING ANTERIORLY, MEDIAL, WHICH IS CONSISTENT WITH IMPLANT DISASSEMBLY. FEMORAL HARDWARE IS IN TACT AND NO RADIOLUCENCY OR JOINT EFFUSION WAS FOUND. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO FRACTURE OF LOCKING BAR FROM THE TIBIAL TRAY ALLOWING THE POLY BEARING TO MOVE WITHIN THE TIBIAL TRAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO FRACTURE OF LOCKING BAR FROM THE TIBIAL TRAY ALLOWING THE POLY BEARING TO MOVE WITHIN THE TIBIAL TRAY. IT WAS FURTHER REPORTED THE PATIENT EXPERIENCED A HARD FALL ON THE KNEE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741232 BIOMET 360 TIBIAL TRAY WITH LOCKING BAR AND SCREW PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 821950

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R