BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET 360 TIBIAL TRAY

    MDR report key: 6592300 · Received May 25, 2017

    Report

    Report Number
    0001825034-2017-03438
    Event Type
    Injury
    Date Received
    May 25, 2017
    Report Date
    September 13, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS-VNGD SSK 360 PSC TIB BRG 16X59 CATALOG#185146 LOT# 295890, VG 360 UNIV PST FM AUG 60X10 CATALOG# 185422 LOT# 308750, VG 360 DST FM AG 60X10 RL/LM CATALOG# 185382 LOT# 666980, VG 360 UNIV PST FM AUG 60X10 CATALOG# 185422 LOT# 706040, BMT SPLINED KNEE STM 16X160 BO CATALOG# 141876 LOT# 904000, VG 360 DST FM AG 60X15 LL/RM CATALOG# 185482 LOT# 594790, VNGD SSK 360 L FEM 60MM CATALOG# 185282 LOT# 3208448, BMT SPLINED KNEE STM V2 13X160 CATALOG# 148327, RGX CONE AUG POR TI 25MM XSM CATALOG# 184601. 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 · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 · 1

    IT WAS REPORTED THAT PATIENT IS INDICATED FOR A REVISION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371866 BIOMET 360 TIBIAL TRAY PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 430490

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ..