BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING 14MM

    MDR report key: 9174410 · Received October 10, 2019

    Report

    Report Number
    0001825034-2019-04575
    Event Type
    Injury
    Date Received
    October 10, 2019
    Date of Event
    November 8, 2004
    Report Date
    January 15, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K002757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATE/CORRECTED UPDATED: B4, B5, D4, G4, G7, H2, H3, H4, H6. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICES OR MEDICAL RECORDS WERE RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 150477, OSS POLY FEMORAL BUSHINGS, LOT # 28110; 150476, OSS POLY TIBIAL BUSHING, LOT # 292630; 150478, OSS POLY LOCK PIN, LOT # 250390; 150465, OSS 5CM DIAPHYSEAL SEGMENT, LOT # 012130; 150467, OSS 9CM DIAPHYSEAL SEGMENT, LOT # 817240. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 04573, 0001825034 - 2019 - 04574, 0001825034 - 2019 - 04576, 0001825034 - 2019 - 04577, 0001825034 - 2019 - 04578.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971235 OSS TIBIAL POLY BEARING 14MM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 045180

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10