BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS LONG TIBIAL PLATE

    MDR report key: 7467456 · Received April 26, 2018

    Report

    Report Number
    0001825034-2018-02973
    Event Type
    Injury
    Date Received
    April 26, 2018
    Date of Event
    July 14, 2017
    Report Date
    June 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS EVALUATED THROUGH A MANUFACTURING REVIEW, BUT THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A ROOT CAUSE CANNOT BE DETERMINED, AS THE INFORMATION NEEDED

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: OSS REINFORCED YOKE, CATALOG #: 150493, LOT #: 446840; OSS POLYETHYLENE LOCKING PIN, CATALOG #: 150478, LOT #: 969830; OSS TIBIAL POLYETHYLENE BEARING, CATALOG #: 150411, LOT #: 771160; OSS POLYETHYLENE TIBIAL BUSHING, CATALOG #: 150476, LOT #: 219940; 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 PRODUCT LOCATION IS UNKNOWN. 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: 0001825034-2018-02972, 0001825034-2018-02973, 0001825034-2018-02974, 0001825034-2018-02975, 0001825034-2018-02976.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE PATIENT UNDERWENT A REVISION DUE TO TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306401 OSS LONG TIBIAL PLATE PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 329680

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R