BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP AS TIB BRG RM/LL 10X67

    MDR report key: 7292314 · Received February 23, 2018

    Report

    Report Number
    0001825034-2018-01386
    Event Type
    Injury
    Date Received
    February 23, 2018
    Report Date
    February 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK132873
    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: 0001825034-2018-01383, 0001825034-2018-01384, 0001825034-2018-01385. CONCOMITANT MEDI AL PRODUCTS: 195907 VANG XP INLK FEMORAL RT 57.5 LOT 516580, 195752 VANG XP INLK PRI TIB TRAY 65 MM LOT 963440, 195773 VGXP XP LAT TIB BRG RT 10X63 LOT 811160, (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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    CLINICAL STUDY (B)(6) - THE PATIENT HAD A KNEE IMPLANT ON (B)(6) 2016 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
    137111 VGXP AS TIB BRG RM/LL 10X67 PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 825180

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other