BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM TIBIAL TRAY

    MDR report key: 7292312 · Received February 23, 2018

    Report

    Report Number
    0001825034-2018-01380
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    August 30, 2016
    Report Date
    February 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    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 - 01379, 0001825034 - 2018 - 01381, 0001825034 - 2018 - 01382. CONCOMITANT PRODUCTS: 195920 VGXP INTLK FEMORAL LT 60, LOT 516440. 195816 VGXP XP E1 TIB BRG LL 11X71, LOT 812000. 195886 VGXP XP E1 TIB BRG LM 11X71, LOT 979060. REPORT SOURCE: FOREIGN. THE EVENT OCCURRED IN (B)(4). 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

    CLINICAL STUDY 505 - THE PATIENT HAD A KNEE IMPLANT AND HAD MENTIONED PROBLEMS PERFORMING USUAL ACTIVITIES, SLIGHTLY PAINFUL TO STAND UP, OCCASIONAL LIMPING, MODERATE DIFFICULTY IN KNEEL DURING HIS 6 MONTH FOLLOW UP VISIT AND ALSO MENTIONED PROBLEMS WALKING, PERFORMING USUAL ACTIVITIES, MODERATE PAIN, IMPOSSIBLE TO KNEEL AND MODERATE DIFFICULT TO DO SHOPPING ON OWN DURING HIS ONE YEAR FOLLOW UP VISIT. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137109 VANGUARD COMPLETE KNEE SYSTEM TIBIAL TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 036250

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other