BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP XP E1 TIB BRG RM 10X71

    MDR report key: 7290938 · Received February 22, 2018

    Report

    Report Number
    0001825034-2018-01308
    Event Type
    Injury
    Date Received
    February 22, 2018
    Date of Event
    February 3, 2015
    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
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01305, 0001825034-2018-01306, 0001825034-2018-01307,. CONCOMITANT PRODUCTS: CAT 195205 ¿ LOT 934930 - VGXP INTLK FMRL RT, CAT 195757 ¿ LOT 677780 ¿ VGXP XP INLK PRI TIB TRAY, CAT 195779 ¿ LOT 641410 ¿ VGXP XP E1 TIB BRG RL. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, THEREFORE A VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PN 195850 LN 597010; REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DEVIATION AND ANOMALIES. THIS DEVICE IS USED FOR TREATMENT. THE REPORTED COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. NO MEDICAL RECORDS RECEIVED. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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

    CLINICAL STUDY (B)(6) REPORTED THAT 6 MONTHS POST A TOTAL KNEE ARTHROPLASTY PROCEDURE THAT WAS CARRIED OUT ON THE RIGHT KNEE ON (B)(6) 2014, THE PATIENT REPORTED PAIN AND DISCOMFORT ALONG WITH PROBLEMS IN WALKING ABOUT AND PERFORMING USUAL ACTIVITIES, FOUND IT DIFFICULT TO STAND UP, WALKED WITH A LIMP, FOUND IT MODERATELY DIFFICULT TO KNEEL, EXPERIENCED PAIN FROM THE KNEE MOST NIGHTS, PAIN GREATLY INTERFERED WITH USUAL WORK AND THE PATIENT WAS HOUSEBOUND. PATIENT'S SATISFACTION RATING AT 6-MONTHS WAS "NOT SATISFIED/I HAVE NEVER BEEN HAPPY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134498 VGXP XP E1 TIB BRG RM 10X71 PROSTHESIS - KNEE MBH ZIMMER BIOMET, INC. N/A 597010

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other