BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING 12MM

    MDR report key: 6900872 · Received September 28, 2017

    Report

    Report Number
    0001825034-2017-07520
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    May 26, 2015
    Report Date
    September 28, 2017
    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
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS - ITEM # UNKNOWN KNEE, ITEM # 150350; LOT#838470; OSS 3 CM RESURFACING FEMORAL RT, ITEM # 150356; LOT#798480; OSS 7 CM SEG ELLIPT FEMORAL R, ITEM: 150493; LOT#UNK; OSS REINFORCED YOKE, ITEM # 150480; LOT#867690; OSS AXLE. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REVIEW OF DEVICE HISTORY RECORDS FOUND UNITS RELEASED FOR DISTRIBUTION WITH NO DEVIATION OR ANOMALY. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL ISSUES REPORTED FOR THIS ITEM. COMPLETION OF INVESTIGATION RELAYED TO SALES REP VIA EMAIL ON 17 SEP 2015. NO RISK ASSESSMENT IS REQUIRED AS THE REVISION WAS DUE TO THE PATIENT¿S ANATOMY. 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 UNDERWENT SEVERAL OSS REVISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680500 OSS TIBIAL POLY BEARING 12MM PROSTHESIS- KNEE JDI ZIMMER BIOMET, INC. N/A 298460

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention