BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINN MOD TIBIAL BEARING STD 22

    MDR report key: 6882663 · Received September 21, 2017

    Report

    Report Number
    0001825034-2017-07087
    Event Type
    Injury
    Date Received
    September 21, 2017
    Date of Event
    August 7, 2009
    Report Date
    September 13, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK945028
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: P/N 150479 OSS REINFORCED YOKE L/N 412810, P/N 153803 FINN SEGMENTAL RT FEMORAL L/N 129420, P/N 153851 FINN TIBIAL BUSHING L/N 126190, P/N 153852 FINN FEMORAL BUSHING SET OF 2 L/N 234670, P/N 153872 FINN AXLE L/N 241740, P/N 153992 FINN MOD TIBIAL BEARING STD 22 L/N 992340, P/N 150410 OSS TIBIAL POLY BEARING 12MM L/N 249130, P/N 150443 OSS MOD PROX TIB 9CM L/N 811890. P/N 150446 OSS CMNTD PROX TIB STEM 13X150 L/N 023950. P/N 153841 FINN LG LOCKING SCREW L/N 139210. P/N 150479 OSS REINFORCED YOKE L/N 412810. P/N 153803 FINN SEGMENTAL RT FEMORAL L/N 129420. P/N 153851 FINN TIBIAL BUSHING L/N 126190, P/N 153852 FINN FEMORAL BUSHING SET OF 2 L/N 234670, P/N 153872 FINN AXLE L/N 241740. 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 THE PATIENT WAS REVISED DUE TO A RIGHT KNEE INFECTION. WARMTH, SWELLING, PAIN, AND DISCOMFORT WERE REPORTED. IT SHOULD BE NOTED, THE PATIENT HAS BEEN ON CHRONIC ANTIBIOTIC SUPPRESSION SINCE THE AGE OF 13. UPON STOPPING THE USE OF THE ANTIBIOTICS, THE PATIENT DEVELOPED COAG-NEGATIVE STAPHYLOCOCCUS INFECTION OF HER RIGHT KNEE. AN IRRIGATION AND DEBRIDEMENT AS WELL AS A ONE-STAGE EXCHANGE PROCEDURE WAS PERFORMED. UPON ENTERING THE JOINT SPACE, IT WAS FOUND TO BE FILLED WITH PURULENT MATERIAL, WHICH WAS DRAINED. THE JOINT WAS INSPECTED AND THE POLYETHYLENE SPACER OF 12 MM THICKNESS WAS FOUND TO BE FRACTURED ANTERIORLY JUST BENEATH THE MEDIAL FEMORAL CONDYLE. THE AXLE, BUSHINGS AND YOKE WERE SUBSEQUENTLY REMOVED ALONG WITH THE BEARING SURFACE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662869 FINN MOD TIBIAL BEARING STD 22 PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 992340

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R