BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET FINNED PRI STEM 40MM

    MDR report key: 10793349 · Received November 5, 2020

    Report

    Report Number
    0001825034-2020-04011
    Event Type
    Injury
    Date Received
    November 5, 2020
    Report Date
    February 18, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OIY
    PMA / PMN Number
    K915132
    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 · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. UPDATED: B4, B5, B6, B7, G4, G7, H1, H2, H6.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS 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. MEDICAL RECORDS REVIEW INDICATES THAT METAL ALLERGY TO MERCURY, NICKEL, TIN, CHROMIUM, VANADIUM AND ZIRCONIUM. POPPING AND CLUNK WITH PROSTHESIS. FEMORAL COMPONENT IS SLIGHTLY ROTATED INTO FLEXION 5-10 DEGREES. LYTIC LINES ALONG CEMENT MANTLE, ESPECIALLY ALONG FEMORAL COMPONENT. MECHANICAL LOOSENING OF THE KNEE. X-RAYS SHOW NO EVIDENCE OF HARDWARE COMPLICATION WITH MILD JOIN EFFUSION AND SOFT TISSUE SWELLING. BONE SCAN SHOWS ABNORMAL ASYMMETRIC UPTAKE OF RADIOPHARMACEUTICAL AROUND THE TOTAL KNEE HARDWARE IN THE LEFT KNEE. MOST PROMINENT AROUND THE FEMORAL COMPONENT WITH ACTIVITY AROUND THE TIBIAL COMPONENT. BY END OF THE DAY LEFT LEG IS SWOLLEN CAUSING THE KNEE TO BE STIFF. A BAKERS CYST POPS OUT BEHIND THE KNEE BY THE END OF THE DAY CAUSING SHARP PAIN INSIDE OF THE KNEECAP. SYNOVITIS OF THE JOINT OF THE LEFT KNEE LIKELY DUE TO REACTION TO THE METALS. NO EVIDENCE OF LOOSENING AND CULTURES ARE ALL NEGATIVE. 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

    FROM ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT THE PATIENT HAS INDICATED FOR REVISION DUE TO METAL ALLERGIES, PAIN, SWELLING, STIFFNESS AND SYNOVITIS. ALSO DUE TO OSTEOLYSIS, NOISE/CLUNKING, LOOSENING AND MIGRATION. FURTHER, OFFICE NOTES INDICATE THAT THE LEG IS SWOLLEN AT THE END OF THE DAY CAUSING IT TO BE STIFF. A BAKER'S CYST POPS OUT BEHIND THE KNEE CAUSING SHARP PAIN TO THE INSIDE OF THE KNEECAP.

    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: PRODUCT ID: VNGD TI FEM PS 65MM LT, CATALOG #: CP113639. LOT # 390450. PRODUCT ID: BIOMET ILOK PRI TIB TRAY 63MM, CATALOG #: 141211, LOT # 983340. PRODUCT ID: VNGD PS TIB BRG 11X63/67, CATALOG #: 183621, LOT # 649610. PRODUCT ID: SERIES A ASYMMETRIC PAT 31X8, CATALOG #: 184792, LOT # 711690. PRODUCT ID: SIMPLEX CEMENT, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MULTIPLE MDR: 0001825034-2020-03853, 0001825034-2020-03854. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED 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 THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. PATIENT ALLEGES TO BE ALLERGIC TO ZIRCONIUM AND CHROMIUM. SUBSEQUENTLY, THE PATIENT HAS INDICATED FOR REVISION DUE TO METAL ALLERGIES, PAIN, SWELLING, STIFFNESS AND SYNOVITIS. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. 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
    1260011 BIOMET FINNED PRI STEM 40MM PROSTHESIS, KNEE OIY ZIMMER BIOMET, INC. N/A 530850

    Patients

    Seq Age Sex Outcome Treatment
    1 Other