BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT MD SIZE 3 PMA

    MDR report key: 7344795 · Received March 16, 2018

    Report

    Report Number
    3002806535-2018-00491
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    January 5, 2015
    Report Date
    March 16, 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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE REPORTED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED EVENTS: 3002806535 - 2018 - 00489, 3002806535 - 2018 - 00490. CONCOMITANT PRODUCT(S): A 161469, OXF TWIN-PEG CMNTD FEM MD PMA LOT 534340; CAT 154725 ¿ LOT 507470 ¿ OXFORD PKS COCR SIZE D RM STD; CAT 159575 ¿ LOT 215120 ¿ OXF ANAT BRG RT MD PMA. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN CLINICAL STUDY 453 THAT A PATIENT HAD POST-OPERATIVE PAIN AND OTHER EXPERIENCES WERE REPORTED AT THE FOLLOW UP VISITS: SIX MONTH EQ5D - PROBLEMS WALKING ABOUT, PROBLEMS PERFORMING USUAL ACTIVITES, EXTREME PAIN AND OXFORD - SEVERE PAIN, VERY PAINFUL TO STAND UP, EXTREMELY DIFFICULT TO KNEEL, TROUBLED BY PAIN IN BED EVERY NIGHT, GREATLY INTERFERED WITH USUAL WORK, MODERATELY DIFFICULT TO SHOP, MODERATELY DIFFICULT TO WALK DOWN STAIRS; 1 YEAR EQ5D - MODERATE PAIN; KNEE SS - MODERATE PAIN AND OXFORD - MODERATE PAIN, AND MODERATELY DIFFICULT TO KNEEL. AT THIS TIME THERE IS NO INDICATION OF SURGICAL DELAYS OR MEDICAL INTERVENTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188824 OXF ANAT BRG RT MD SIZE 3 PMA PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 215120

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other