BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP XP MED TIB BRG LT 10X63

    MDR report key: 7310217 · Received March 2, 2018

    Report

    Report Number
    0001825034-2018-01316
    Event Type
    Injury
    Date Received
    March 2, 2018
    Date of Event
    August 23, 2016
    Report Date
    February 22, 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: 0001825034-2018-01313, 0001825034-2018-01314, 0001825034-2018-01315. CONCOMITANT PRODUCTS: CAT 195917 ¿ LOT 331390 - VANG XP INLK FEMORAL, CAT 195751 ¿ LOT 585400 ¿ VANG XP INLK PRI TIB TRAY, CAT 195807 ¿ LOT 173550 - VGXP XP LAT TIB BRG LT. (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, THEREFORE A VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORT EVENT WAS NOT REPORTED. 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 THAT THE PATIENT HAD KNEE IMPLANTATION IN BOTH THE KNEES. POST-OPERATIVELY, THE PATIENT HAS MENTIONED PROBLEMS WITH LEFT KNEE THAT INCLUDE MODERATE PAIN STANDING UP, OCCASIONAL LIMPING, IMPOSSIBLE TO KNEEL, INTERFERENCE WITH WORK DUE TO PAIN AND MODERATE DIFFICULTY IN WALKING DOWN STAIRS DURING THE SIX MONTH FOLLOW UP VISIT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153946 VGXP XP MED TIB BRG LT 10X63 PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 979020

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other