BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 5CM DIAPHYSEAL SEGMENT

    MDR report key: 9150299 · Received October 3, 2019

    Report

    Report Number
    0001825034-2019-04429
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    January 30, 2012
    Report Date
    February 21, 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

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE NOT PROVIDED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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 PRODUCT(S): 150410, OSS TIBIAL POLY BEARING 12MM, LOT # 520820; 150467 OSS 9CM DIAPHYSEAL SEGMENT, LOT # 289150; 150476, POLY TIBIAL BUSHING, LOT # 143560; 150477, POLY FEMORAL BUSHING, LOT # 050320; 150478, OSS POLY LOCK PIN, LOT # 143560; 150479, OSS REINFORCED YOKE, LOT # 125790; 150355, OSS 7 CM SEGMENTAL FEMORAL LT, LOT 203000; 150367, OSS CEMENTED IM STEM, LOT # 240470; 150480, OSS AXLE, LOT #178390. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2016 - 03780, 0001825034 - 2019 - 04425, 0001825034 - 2019 - 04426, 0001825034 - 2019 - 04427, 0001825034 - 2019 - 04428, 0001825034 - 2019 - 04430, 0001825034 - 2019 - 04431, 0001825034 - 2019 - 04432, 0001825034 - 2019 - 04433.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 7 YEARS 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
    944627 OSS 5CM DIAPHYSEAL SEGMENT PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 508870

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R