BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP INTLK FMRL RT 60

    MDR report key: 7279766 · Received February 19, 2018

    Report

    Report Number
    0001825034-2017-10875
    Event Type
    Injury
    Date Received
    February 19, 2018
    Date of Event
    April 3, 2014
    Report Date
    February 19, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK122160
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: PART 195203, LOT 503670- VGXP INTLK FMRL RT 60. PART 195251, LOT 936260- VNGD XP INLK PRI TIB TRAY 75 MM. PART 195333, LOT 867980 - VGXP XP E1 TIB BRG RL 10X71. PART 195402, LOT 868540- VGXP XP E1 TIB BRG RM 9X71. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: MFR 0001825034-2018-10876, MFR 0001825034-2018-10881, MFR 0001825034-2018-10882. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THIS COMPLAINT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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. IT WAS ALSO REPORTED THAT THE PATIENT FOUND IT IMPOSSIBLE TO KNEEL, FELT THAT THE PAIN GREATLY INTERFERED WITH USUAL WORK, FELT MODERATELY PAINFUL TO STAND UP, EXPERIENCED PAIN DURING THE NIGHTS FROM THE KNEE, FOUND IT DIFFICULT TO GET IN AND OUT OF THE CAR ALONG WITH EXPERIENCING PAIN WITHIN 5-15 MIN OF WALKING. IT WAS ALSO REPORTED THAT THE PATIENT FOUND IT IMPOSSIBLE TO WALK DOWN A FLIGHT OF STAIRS. THE PATIENT WAS HOUSEBOUND AND USING CRUTCHES OR A WALKER. IT WAS FURTHER REPORTED THAT DURING THE 1 YEAR POST OP FOLLOW UP VISIT THE PATIENT STILL EXPERIENCED THE SAME DIFFICULTIES SHE DID DURING THE 6 MONTHS POST OP VISIT BUT NO LONGER WAS HOUSEBOUND OR USING CRUTCHES/WALKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123175 VGXP INTLK FMRL RT 60 PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 503670

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other