BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINN ROTATING HINGE FEMORAL BUSHING

    MDR report key: 7386862 · Received March 30, 2018

    Report

    Report Number
    0001825034-2018-02283
    Event Type
    Injury
    Date Received
    March 30, 2018
    Date of Event
    April 24, 2018
    Report Date
    April 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK910877
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY UPDATED AND ADDITIONAL INFORMATION. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00276-1, 0001825034-2018-00277-1, 0001825034-2018-00278-1, 0001825034-2018-00279-1, 0001825034-2018-00280-1, 0001825034-2018-00281-1, 0001825034-2018-00282-1, 0001825034-2018-00283-1, 0001825034-2018-00284-1, 0001825034-2018-00285-1, 0001825034-2018-00286-1.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THE PATIENT UNDERWENT A RIGHT KNEE REVISION 28 YEARS POST-IMPLANTATION DUE TO PAIN.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: FINN ROTATING HINGE AXEL, CATALOG #: RD108802, LOT #: 717090; FINN ROTATING HINGE YOKE, CATALOG #: RD108801, LOT #: 537700; FINN ROTATING HINGE LOCKING PIN, CATALOG #: RD108804, LOT #: 462840; FINN ROTATING HINGE TIBIAL BUSHING, CATALOG #: RD108806, LOT #: 717110; FINN STANDARD TIBIAL BASE, CATALOG #: RD108834, LOT #: 763090; FINN DISTAL FEMORAL DIAPHYSIS, CATALOG #: PM100271, LOT #: 730110; FINN STANDARD TIBIAL BEARING, CATALOG #: RD108810, LOT #: 717120; FINN FEMORAL LOCKING COLLAR, CATALOG #: RD108515, LOT #: 231050; FINN ROTATING HINGE FEMORAL BUSHING, CATALOG #: RD108803, LOT #: 717100; BL2 MODULAR STEM, CATALOG #: CP101648, LOT #: 745890. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00276, 0001825034-2018-00277, 0001825034-2018-00278, 0001825034-2018-00279, 0001825034-2018-00280, 0001825034-2018-00281, 0001825034-2018-00282, 0001825034-2018-00283, 0001825034-2018-00284, 0001825034-2018-00285, 0001825034-2018-00286. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS CONSIDERED FOR A REVISION SURGERY ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227415 FINN ROTATING HINGE FEMORAL BUSHING PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 717100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R