BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM INTERLOK TITANIUM VANGUARD PS FEMORAL LEFT 60MM

    MDR report key: 6609379 · Received June 2, 2017

    Report

    Report Number
    0001825034-2017-03589
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    June 6, 2017
    Report Date
    November 8, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK080204
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: BIOMET MAXIM MODULAR FINNED STEM 40MM, ITEM # 141314, LOT # 023400. BIOMET ARCOM PATELLA W/WIRE 34MM, ITEM # 11-150828, LOT # 293000. BIOMET PRIMARY INTERLOK TIBIAL TRAY 67MM, ITEM # 141212, LOT # 015530. BIOMET SIGNATURE TKA GDE/MDL SET, ITEM # 42-422561, LOT # 071746. BIOMET VANGUARD PS TIBIAL BEARING, ITEM # 183724, LOT # 986710. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO DEVICE REMAINING IMPLANTED IN THE PATIENT. 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: 0001825034-2017-03586, 0001825034-2017-03587, AND 0001825034-2017-03588.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER AN INITIAL KNEE ARTHROPLASTY, THE PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388750 CUSTOM INTERLOK TITANIUM VANGUARD PS FEMORAL LEFT 60MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 263620 

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention