BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY

    MDR report key: 7398730 · Received April 5, 2018

    Report

    Report Number
    0001825034-2018-01926
    Event Type
    Injury
    Date Received
    April 5, 2018
    Date of Event
    August 15, 2017
    Report Date
    June 1, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - BMET ARCOM AP PAT CAT#: 11-150830, LOT#: 453730, MAXIM POR ANA PRI CAT#: 140051, LOT#: 583780, BIOMET FINNED PRI CAT#: 141314, LOT#: 290950 , MAX PRI-LIP TIB BR CAT#: 146336, LOT#: 735410. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07028-1 AND 0001825034-2017-07029-1. PRODUCT LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE PRODUCT COULD NOT BE EVALUATED, BUT THE PATIENT¿S DISLOCATION WAS CONFIRMED THROUGH RADIOGRAPHIC REVIEW. HOWEVER, THE INSTABILITY AND PATELLAR WEAR WERE UNABLE TO BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE UNABLE TO BE REVIEWED AS THE RECORD COULD NOT BE FOUND. A RADIOGRAPHIC REVIEW INDICATED THAT THE RIGHT KNEE HAD EVIDENCE OF ANTERIOR DISLOCATION OF THE TIBIA, BUT NO RADIOLUCENCY OR ACUTE FRACTURE. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND PATELLA WEAR. THE X-RAY REVIEW CONFIRMED AN ANTERIOR DISLOCATION OF THE TIBIA. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242227 BIOMET CC CRUCIATE TRAY PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 180990

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R