BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM PRIMARY TIBIAL BEARING 10MM THICK X 79/83MM WIDE

    MDR report key: 6480457 · Received April 11, 2017

    Report

    Report Number
    0001825034-2017-02488
    Event Type
    Injury
    Date Received
    April 11, 2017
    Date of Event
    March 14, 2017
    Report Date
    May 24, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCT - BMET ARCOM AP PAT W/WIRE 34MM CATALOG# 11-150828 LOT# 652280, MAXIM POR PRI TIB TRAY 79MM CATALOG# 141265 LOT# 654010, MAXIM POR ANA PRI FML 70 LT CATALOG# 140073 LOT# 229640, TI LOW PROFILE SCREW 6.5X35MM CATALOG# 103534 LOT# 318115, TI LOW PROFILE SCREW 6.5X20MM CATALOG# 103531 LOT# 590390, TI LOW PROFILE SCREW 6.5X40MM CATALOG# 103535 LOT# 114970, MAX FINNED PRIMARY STEM 40MM CATALOG# 141314 LOT# 209760, BIOMET TIBIAL LOCKING BAR CATALOG# 141205 LOT# 040090. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT IS STILL IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED TO A THICKER BEARING DUE TO LIGAMENT LAXITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A KNEE ARTHROPLASTY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY. THE DATE AND CAUSE OF THE REVISION IS CURRENTLY UNKNOWN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVEN IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264060 MAXIM PRIMARY TIBIAL BEARING 10MM THICK X 79/83MM WIDE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 893520

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention