BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI TIB TRAY SZ C RM PMA

    MDR report key: 19228118 · Received May 2, 2024

    Report

    Report Number
    3002806535-2024-00159
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    April 10, 2024
    Report Date
    May 2, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279388899
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED PRODUCTS: ITEM #161470, ITEM NAME OXF TWIN-PEG CMNTD FEM LG PMA, LOT #534630. ITEM #159582, ITEM NAME OXF ANAT BRG RT LG SIZE 3 PMA, LOT #948840. ITEM #402283, ITEM NAME COBALT G-HV BONE CEMENT 40G, LOT #030420. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456974 OXFORD UNI TIB TRAY SZ C RM PMA KNEE IMPLANT NRA BIOMET UK LTD. N/A 558950 05019279388899

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H