BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANG XP INLK FEMORAL RT 57.5

    MDR report key: 7292313 · Received February 23, 2018

    Report

    Report Number
    0001825034-2018-01383
    Event Type
    Injury
    Date Received
    February 23, 2018
    Report Date
    February 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK141407
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01384, 0001825034 - 2018 - 01385, 0001825034 - 2018 - 01386. CONCOMITANT PRODUCT(S): A 195752 VANG XP INLK PRI TIB TRAY 65MM LOT 963440; 195773 VGXP XP LAT TIB BRG RT 10X63 LOT 811160; 195606 VGXP AS TIB BRG RM/LL 10X67 LOT 825180. REPORT SOURCE: FOREIGN. THE EVENT OCCURRED IN (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A KNEE IMPLANT AND HAD MENTIONED SOME PROBLEMS WALKING, WASHING/DRESSING, MODERATE PAIN, PAIN DURING STANDING UP, OCCASIONAL LIMPING, IMPOSSIBILITY TO KNEEL, EXTREME DIFFICULTY WALKING DOWN STAIRS, TROUBLED SLEEP DUE TO PAIN, AND INTERFERENCE WITH USUAL ACTIVITIES DURING HER 6 MONTH FOLLOW UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137110 VANG XP INLK FEMORAL RT 57.5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 516580

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other