BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING 12MM

    MDR report key: 18582494 · Received January 25, 2024

    Report

    Report Number
    0001825034-2024-00175
    Event Type
    Injury
    Date Received
    January 25, 2024
    Date of Event
    January 4, 2024
    Report Date
    June 26, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304239388
    PMA / PMN Number
    K002757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4; B5; G3; H2; H3; H6; H11. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SIGNS OF BEING IMPLANTED IN THE FORM OF WEAR AND DISCOLORATION ALONG WITH THE IMPLANT HAVING CRACKS AND TORN EDGES. THE DEVICE WAS SUBMITTED FOR FURTHER ANALYSIS. ANALYSIS DETERMINED THE INFERIOR SIDE SHOWS SOME SCUFFING AND POSSIBLE GOUGING OR ABRASIONS THAT ARE TYPICAL WITH IN-VIVO USE. IN THE POCKET FOR THE YOKE, THERE APPEARS TO BE PLASTIC DEFORMATION AND DAMAGE FROM YOKE PENTATION INTO THE UHWMPE MATERIAL. THE MATERIAL BETWEEN THE YOKE POCKET AND THE KEYWAY ALSO HAS SOME PLASTIC DEFORMATION IN IT AND APPEARS TO HAVE BEEN SUBJECTED TO A PUSHING FORCE FROM THE YOKE. THE SUPERIOR SIDE HAS SOME PLASTIC DEFORMATION AROUND THE YOKE JUST SUPERIOR TO WHERE THE YOKE HAS PENETRATED INTO THE BEARING, AND BOTH SIDES OF THE BEARING HAVE BEEN BREACHED ON THE SUPERIOR SIDE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: CPS NUT CO-CR-MO ALLOY: CATALOG#178512, LOT#025940; CPS 7CM SEG FM OSS TPR LT: CATALOG#178713, LOT#243240; OSS POLY FEMORAL BUSHINGS: CATALOG#150477, LOT#365540; OSS AXLE: CATALOG#150480, LOT#361790; CPS ELLIP SPDL W PINS 800LBF: CATALOG#178361, LOT#877750; OSS REINFORCED YOKE: CATALOG#150493, LOT#437040; OSS POLY LOCK PIN: CATALOG#150478, LOT#724830; OSS POLY TIBIAL BUSHING: CATALOG#150476, LOT#406200; CPS ANCHOR PLUG 22MM: CATALOG#178412, LOT#752810; CPS SHRT CENTERING SLEEVE 27MM: CATALOG#178737, LOT#831060; CPS TRANSVERSE PIN 6PK 36MM: CATALOG#178528, LOT#070970. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION KNEE PROCEDURE. APPROXIMATELY TWO (2) YEARS AND SIX (6) MONTHS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE INSTABILITY. A REVISION PROCEDURE WAS PERFORMED IN WHICH THE ARTICULAR SURFACE WAS FOUND TO BE FRACTURED. THE AFFECTED BEARING WAS REPLACED WITHOUT REPORTED COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899491 OSS TIBIAL POLY BEARING 12MM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. 025680 00880304239388

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization| R SEE H10 NARRATIVE.