BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PAT STD 34 3 PEG

    MDR report key: 8689845 · Received June 11, 2019

    Report

    Report Number
    0001825034-2019-02536
    Event Type
    Injury
    Date Received
    June 11, 2019
    Date of Event
    November 28, 2012
    Report Date
    October 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT CANNOT BE CONFIRMED. MEDICAL RECORDS WERE NOT PROVIDED AND NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE 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). CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR ILOK FEM-RT 70 ITEM# 183012 LOT# 325910, BMET REGENX PRI TIB TRAY 75MM ITEM# 141274 LOT# 278890, BIOMET FINNED PRI STEM 40MM ITEM# 141314 LOT# 896740, VNGD CR TIB BRG 10X71/75 ITEM# 183440 LOT# 560800, COBALT G-HV BONE CEMENT 40G ITEM# 402283 LOT# 768500. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 UNDERWENT A REVISION PROCEDURE APPROXIMATELY NINE MONTHS POST IMPLANTATION DUE TO PAIN, INSTABILITY, AND LOOSENING. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480460 SERIES A PAT STD 34 3 PEG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 857420 

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R