BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK MAXIMUM CONGRUENT KNEE KNEE SYSTEM- BEARING

    MDR report key: 6501167 · Received April 18, 2017

    Report

    Report Number
    0001825034-2017-02650
    Event Type
    Injury
    Date Received
    April 18, 2017
    Date of Event
    April 17, 2017
    Report Date
    August 25, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). CONCOMITANT PRODUCTS: MEDICAL PRODUCT- BIOMET TIBIAL LOCKING BAR CATALOG# 141205 LOT# 153240, MAX ILK ANA OPEN PS FMRL 65 RT CATALOG # 145152 LOT # 780850, BMET ARCOM AP PAT W/WIRE 28MM CATALOG # 11-150825 LOT # 821740, BIOMET FINNED PRI STEM 40MM CATALOG # 141314 LOT # 652620, BIOMET ILOK PRI TIB TRAY 67MM CATALOG # 141212 LOT # 223760. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02651.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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.

    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 MAY REQUIRE A REVISION PROCEDURE DUE TO UNKNOWN REASONS. HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FOUR YEARS POST IMPLANTATION DUE TO LOOSENING OF THE BEARING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281990 MCK MAXIMUM CONGRUENT KNEE KNEE SYSTEM- BEARING PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 183290

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R