BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF UNI TIB TRAY SZ B RM PMA

    MDR report key: 8008497 · Received October 26, 2018

    Report

    Report Number
    3002806535-2018-01165
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    September 11, 2018
    Report Date
    November 19, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SUFFERED AN EPISODE OF SHARP RIGHT KNEE PAIN ON MEDIAL SIDE OF THE PATELLA SECONDARY TO SYNOVITIS AND SCAR IRRITATION. NO MEDICAL INTERVENTION WAS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - OXF TWIN-PEG CMNTD FEM SM PMA, ITEM 161468, LOT 124850, THERAPY DATE - DEVICE REMAINS IMPLANTED, OXF ANAT BRG RT SM SIZE 4 PMA , ITEM 159569, LOT 800600, THERAPY DATE - DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018-01163 AND 3002806535-2018-01164.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A RIGHT PARTIAL KNEE ARTHROPLASTY .SUBSEQUENTLY IT WAS REPORTED THAT THE PATIENT SUFFERED AN EPISODE OF SHARP RIGHT KNEE PAIN ON MEDIAL SIDE OF THE PATELLA SECONDARY TO SYNOVITIS AND SCAR IRRITATION. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848715 OXF UNI TIB TRAY SZ B RM PMA OXFORD CEMENTED TIBIAL TRAYS JWH BIOMET UK LTD. 309300

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR