BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD TWIN-PEG CEMENTED FEMUR MD PMA

    MDR report key: 7037419 · Received November 16, 2017

    Report

    Report Number
    3002806535-2017-01017
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    February 7, 2012
    Report Date
    February 23, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 3002806535 - 2017 - 01017, 3002806535 - 2017 - 01018. UNIQUE DEVICE IDENTIFIER: ((B)(4). CONCOMITANT PRODUCT(S): A 161469 OXF TWIN-PEG CMNTD FEM MD PMA LOT 2465500. A 154724 OXF UNI TIB TRAY SZ D LM PMA LOT 2462031. A 159547 OXF ANAT BRG LT MD SIZE 3 PMA LOT 2485165. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE STUDY THE PATIENT EXPERIENCED AN INCREASE IN LEFT KNEE STIFFNESS. IT WAS DETERMINED NO TREATMENT WAS NECESSARY AND THE OUTCOME WAS CONSIDERED RESOLVED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819004 OXFORD TWIN-PEG CEMENTED FEMUR MD PMA PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 2465500

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other