BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM - VANGUARD PS TIBIAL BEARING 10MM X 79/83 MM

    MDR report key: 6411783 · Received March 16, 2017

    Report

    Report Number
    0001825034-2017-01701
    Event Type
    Injury
    Date Received
    March 16, 2017
    Date of Event
    February 14, 2017
    Report Date
    April 13, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY INVESTIGATION RESULTS. 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 COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS ATTRIBUTED TO POST-SURGICAL TRAUMA NOT RELATED TO THE DEVICE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FLED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND TO CORRECT INFORMATION. CONCOMITANT MEDICAL PRODUCTS - BIOMET ILOK PRI TIB TRAY 79MM CATALOG# 141215 LOT# 735390, VNGD PS OPEN INTL FEM RT 70 CATALOG# 183112 LOT# 551330, BIOMET FINNED PRI STEM 40MM CATALOG# 141314 LOT# 462810, SERIES A 3 PEG STD 37X10 CATALOG# 184768 LOT# 324500. 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 IS REPORTED THAT THE AFTER A KNEE ARTHROPLASTY THAT PATIENT WAS REVISED DUE TO PAIN FROM PATIENT FALL FROM LADDER. SURGEON INDICATED POST TRAUMATIC OSSICFICATION IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190781 VANGUARD COMPLETE KNEE SYSTEM - VANGUARD PS TIBIAL BEARING 10MM X 79/83 MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 251220

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R