BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PFR FEMORAL LT SM

    MDR report key: 7521358 · Received May 17, 2018

    Report

    Report Number
    0009610576-2018-00017
    Event Type
    Injury
    Date Received
    May 17, 2018
    Report Date
    May 15, 2018
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRR
    PMA / PMN Number
    PK000827
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE UNKNOWN. IMPLANT SURGERY WAS (B)(6) 2015. CONCOMITANT MEDICAL PRODUCTS: P/N 184784, LOT 608490. P/N 00-1112-140-01, LOT 80424395. PATIENT REPORTS ALLERGY (BUT NOT CONFIRMED). REF. (B)(4). VANGUARD PFR FEMORAL LT SM WAS CLEARED IN THE U.S. UNDER 510(K) K000827, FDA PRODUCT CODE KRR. THIS EVENT WAS PREVIOUSLY REPORTED BY THE PATIENT UNDER MW5076326. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CONTINUOUSLY WITH PAIN, SWELLING AND STIFFNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364944 VANGUARD PFR FEMORAL LT SM PROSTHESIS, KNEE KRR BIOMET SPAIN, S.L. N/A 2014040696

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability