BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD TWIN-PEG CEMENTED FEM SM PMA

    MDR report key: 7037486 · Received November 16, 2017

    Report

    Report Number
    3002806535-2017-01027
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    August 7, 2017
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 3002806535 - 2017 - 01025, 3002806535 - 2017 - 01026, 3002806535 - 2017 - 01027. CONCOMITANT PRODUCT(S): A 159531 OXF UNI TIB TRAY SZ AA LM PMA LOT 450740. A 159541 OXF ANAT BRG LT SM SIZE 4 PMA LOT 556260. A 161468 OXF TWIN-PEG CMNTD FEM SM PMA LOT 681240. (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS UNKNOWN REASONS. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819132 OXFORD TWIN-PEG CEMENTED FEM SM PMA PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 681240

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R