BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM-TIBIAL TRAY

    MDR report key: 6523708 · Received April 26, 2017

    Report

    Report Number
    0001825034-2017-02794
    Event Type
    Injury
    Date Received
    April 26, 2017
    Report Date
    August 16, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. X-RAY REVIEW IDENTIFIED THAT "FIT OF IMPLANTS APPEARS ADEQUATE; HOWEVER THE ALIGNMENT IS INAPPROPRIATE WITH VARUS ANGULATION OF THE KNEE. BESIDES QUESTIONABLE OSTEOPOROSIS IN THE MEDIAL FEMORAL CONDYLE THE BONE QUALITY APPEARS ADEQUATE. UNCERTAIN WHETHER THE MEDIAL FEMORAL CONDYLE FINDING IS CHRONIC OR NEW--WOULD NEED PRIOR STUDIES TO COMPARE. TIBIAL TRAY HAS SUBSIDED WHICH IMPLIES IT HAS DONE SO AS A RESULT OF LOOSENING". DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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

    CMP-(B)(4) MEDICAL PRODUCT - AGC TRAD PRI TIB BEAR 16X79/83 CATALOG# 151018 LOT# 882310, BMET ARCOM AP PAT 3PST 37MM LG CATALOG# 11-150844 LOT# 922650, BIOMET TIBIAL LOCKING BAR CATALOG# 141205 LOT# 066580 , AGC ANATOMIC POR FMRL 75 RIGHT CATALOG# 152738 LOT# 805990, PALACOS BONE CEMENT 40GRAM CATALOG# 424800 LOT# 003283. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 - 02795.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS A LOOSE TIBIA. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306074 MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM-TIBIAL TRAY PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 890130

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention SEE H10 NARRATIVE