BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET FINNED PRI STEM 40MM

    MDR report key: 9196833 · Received October 16, 2019

    Report

    Report Number
    0001825034-2019-04682
    Event Type
    Injury
    Date Received
    October 16, 2019
    Report Date
    January 30, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBV
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATE/CORRECTED UPDATED: B4, B5, D11, G4, G7, H2, H3, H6. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HCP, BUT DID NOT NOTE ANY PAIN OR MOBILITY ISSUES POST IMPLANTATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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. D11: 184508, FEMORAL COMPONENT, LOT # 318040. 141273, TIBIAL TRAY, LOT # 834180. 184764, PATELLA, LOT # 470450. EP-183640, BEARING, LOT # 464570. 141205, TIBIAL LOCKING BAR, LOT # 884630. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 00460.

    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: 184512 VNGD PS OPEN POR FMRL RT 70, 141275 BMET REGENX PRI TIB TRAY 79MM, UKNOWN 3 PEG PATELLA, UNKNOWN 10 MM E POLY BEARING. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR'S SUBMITTED FOR ASSOCIATED PRODUCTS. LINKS BELOW: 0001825034-2019-04681, 0001825034-2019-04684, 0001825034-2019-04694, 0001825034-2019-04688.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST RIGHT KNEE REVISION ARTHROPLASTY DUE TO IMPLANT FRACTURE AND METALLOSIS, THE PATIENT IS EXPERIENCING PAIN AND MOBILITY DYSFUNCTION INTERFERING WITH DAILY LIFE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992341 BIOMET FINNED PRI STEM 40MM KNEE PROSTHESES MBV ZIMMER BIOMET, INC. N/A 255700

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other SEE H10 NARRATIVE.