BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS PROXIMAL TIBIAL POROUS COATED STEM

    MDR report key: 7453017 · Received April 23, 2018

    Report

    Report Number
    0001825034-2018-02965
    Event Type
    Injury
    Date Received
    April 23, 2018
    Report Date
    October 18, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO THE FACT THAT THE PRODUCT REMAINS IMPLANTED. 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 COULD NOT BE PROVIDED AS THE DEVICE IS STILL IMPLANTED. 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

    NO FURTHER INFORMATION REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OSS REINFORCED YOKE, CATALOG #: 150493, LOT #: 534180, OSS POLYETHYLENE LOCKING PIN, CATALOG #: 150478, LOT #: 888150, OSS TIBIAL POLYETHYLENE BEARING, CATALOG #: 150410, LOT #: 572330, OSS POLYETHYLENE TIBIAL BUSHING, CATALOG #: 150476, LOT #: 158950, OSS POLYETHYLENE LOCKING PIN, CATALOG #: 150478, LOT #: 503200, REGENEREX MULTI-HOLE ACETABULAR CUP, CATALOG #: PT-106062, LOT #: 153470, LOW PROFILE SCREW, CATALOG #: 103533, LOT #: 323010, LOW PROFILE SCREW, CATALOG #: 103532, LOT #: 867290, OSS MODULAR FEMORAL COMPONENT, CATALOG #: 161012, LOT #: 329720, OSS FEMORAL DIAPHYSIS, CATALOG #: 150462, LOT #: 106770, OSS MODULAR PROXIMAL FEMORAL COMPONENT, CATALOG #: 150458, LOT #: 369640, OSS DIAPHYSEAL SEGMENT, CATALOG #: 150467, LOT #: 466190, OSS AXLE, CATALOG #: 161035, LOT #: 204590, HIWALL POLYETHYLENE LINER, CATALOG #: EP-108525, LOT #: 568260, MAGNUM MODULAR HEAD, CATALOG #: S331140, LOT #: 493600, OSS POLYETHYLENE BUSHINGS, CATALOG #: 161034, LOT #: 430130. 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. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A REVISION ON AN UNKNOWN DATE FOR UNKNOWN REASONS. THE PROXIMAL TIBIAL COMPONENT HAS BEEN REQUESTED FOR THE REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293624 OSS PROXIMAL TIBIAL POROUS COATED STEM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 523980

    Patients

    Seq Age Sex Outcome Treatment
    1 Other