BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CRUCIATE RETAINING TIBIAL BEARING

    MDR report key: 6149705 · Received December 6, 2016

    Report

    Report Number
    0001825034-2016-05034
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    November 14, 2016
    Report Date
    April 17, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT - VANGUARD CRUCIATE RETAINING FEMUR, CATALOG# 183002, LOT# 538190; BIOMET REGENEREX TIBIAL TRAY, CATALOG# 141271, LOT# 307330; SERIES A 3 PEG PATELLA, CATALOG# 184784, LOT# 990640; BIOMET FINNED STEM, CATALOG# 141314, LOT# 865690. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PATIENT AGE - NI. PATIENT WEIGHT - NI. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION DUE TO STIFFNESS AND REDUCED RANGE OF MOTION APPROXIMATELY 4 YEARS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798675 VANGUARD CRUCIATE RETAINING TIBIAL BEARING PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 050250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R