BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PAT THN 34 3 PEG

    MDR report key: 10005593 · Received April 28, 2020

    Report

    Report Number
    0001825034-2020-01810
    Event Type
    Injury
    Date Received
    April 28, 2020
    Date of Event
    September 17, 2019
    Report Date
    April 28, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304435749
    PMA / PMN Number
    K040770
    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 · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2019-05362, 0001825034-2019-05365, 0001825034-2019-05366. 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 E1 TIB BRG RL 10X71, ITEM# 195780, LOT# 476510; VGXP XP INLK PRI TIB TRAY 75MM, ITEM# 195757, LOT# 111730; UNKNOWN PALACOS CEMENT. REPORT SOURCE - (B)(6). 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 · 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
    471468 SERIES A PAT THN 34 3 PEG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 524530 00880304435749

    Patients

    Seq Age Sex Outcome Treatment
    1 Other