BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT MD SIZE 5 PMA

    MDR report key: 7364952 · Received March 23, 2018

    Report

    Report Number
    3002806535-2018-00576
    Event Type
    Injury
    Date Received
    March 23, 2018
    Date of Event
    November 3, 2016
    Report Date
    April 26, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). MEDICAL PRODUCT - OXF UNI TIB TRAY SZ C LM PMA, ITEM 154725, LOT 2674712; THERAPY DATE- (B)(6) 2016. MEDICAL PRODUCT - OXF TWIN-PEG CMNTD FEM MD PMA , ITEM 1161469, LOT 2715558; THERAPY DATE - (B)(6) 2016. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018-00406-1 AND 3002806535-2018-0575.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS 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 · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY PATIENT WAS REVISED DUE TO ON GOING PAIN AND SIGNIFICANT RANGE OF MOTION LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208472 OXF ANAT BRG RT MD SIZE 5 PMA JWH BIOMET UK LTD. N/A 2518362

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R