BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINN DISTAL FEMORAL DIAPHYSIS

    MDR report key: 7386848 · Received March 30, 2018

    Report

    Report Number
    0001825034-2018-02281
    Event Type
    Injury
    Date Received
    March 30, 2018
    Report Date
    April 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. 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

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    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 STANDARD TIBIAL BEARING, CATALOG #: RD108810, LOT #: 717120; FINN ROTATING HINGE FEMORAL BUSHING, CATALOG #: RD108803, LOT #: 717100; 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
    227530 FINN DISTAL FEMORAL DIAPHYSIS PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 730110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other