BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP XP E1 TIB BRG RL 10X71

    MDR report key: 9382667 · Received November 27, 2019

    Report

    Report Number
    0001825034-2019-05366
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    September 17, 2019
    Report Date
    April 28, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    UDI-DI
    00880304552388
    PMA / PMN Number
    K132873
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. PRIMARY OPERATIVE NOTES DO NOT SUGGEST ANY INTRA OPERATIVE COMPLICATIONS. OFFICE NOTES FROM SIX WEEK FOLLOW UP TO ONE YEAR CONFIRM PATIENT HAD PAIN, STIFFNESS AND A DECREASE IN FLEXION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. ROOT CAUSE CANNOT BE DETERMINED. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2019-05362, 0001825034-2019-05365. CONCOMITANT MEDICAL PRODUCTS: VGXP INTLK FEMORAL RT 67.5 , ITEM# 195911, LOT# 070690. VGXP XP E1 TIB BRG RM 10X71, ITEM# 195850, LOT# 109960. VGXP XP INLK PRI TIB TRAY 75MM, ITEM# 195757, LOT# 111730. SERIES A PAT THN 34 3 PEG, ITEM# 184786, LOT# 524530. UNKNOWN PALACOS CEMENT. REPORT SOURCE - UNITED KINGDOM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT REPORTED A DECREASE IN FLEXION AND INCREASE IN PAIN AND STIFFNESS APPROXIMATELY ONE-YEAR POST IMPLANTATION. NO REVISION OR INTERVENTION HAS BEEN NOTED AT THIS TIME. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176876 VGXP XP E1 TIB BRG RL 10X71 PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 476510 00880304552388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other