BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ B LM PMA

    MDR report key: 6658556 · Received June 21, 2017

    Report

    Report Number
    3002806535-2017-00522
    Event Type
    Injury
    Date Received
    June 21, 2017
    Report Date
    December 15, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: OXFORD FEMORAL CATALOG# 161469 LOT# 504950, OXFORD BEARING CATALOG# 159548 LOT# 437610, COBALT BONE CEMENT CATALOG# 402282 LOT# 699600, OXFORD RESECTION CATALOG# 506124 LOT# 942051, GUIDE CATALOG# 42-411572 LOT# 111189. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION DUE TO TIBIAL LOOSENING AFTER APPROXIMATELY THREE YEARS POST IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS SCHEDULED FOR A REVISION DUE TO TIBIAL LOOSENING AFTER APPROXIMATELY THREE YEARS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437315 OXF UNI TIB TRAY SZ B LM PMA PROSTHESIS, KNEE NRA BIOMET UK LTD. 3002828 

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention