BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 67MM

    MDR report key: 6173581 · Received December 14, 2016

    Report

    Report Number
    0001825034-2016-05201
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    November 15, 2016
    Report Date
    March 8, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTOR WITH NO DEVIATIONS OR ABNORMALITIES. PRODUCT WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. THIS DEVICE IS USED FOR TREATMENT THE COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. FURTHERMORE, LOOSENING ATTRIBUTED TO PATIENT FALL, NOT CAUSED BY IMPLANTS, SO A PRODUCT ISSUE IS NOT INDICATED ROOT CAUSE ATTRIBUTED TO PATIENT FALL THAT WAS NOT CAUSED BY IMPLANTS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: VANGRD CR LIP TIB BRG, CATALOG# 183526, LOT# 637960; SERIES A PAT THN 28 3, CATALOG# 184782, LOT# 103040; VANGUARD CR ILOK FEM-L, CATALOG# 183026, LOT# 808820.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE DUE TO TIBIAL TRAY LOOSENING WHICH WAS CAUSED FROM THE PATIENT FALLING APPROXIMATELY SIX (6) YEARS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824040 BIOMET CC CRUCIATE TRAY 67MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 753690

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R