BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT ¿ BIOMET ALL POLY PAT. BUTTON

    MDR report key: 6544152 · Received May 4, 2017

    Report

    Report Number
    0001825034-2017-03078
    Event Type
    Injury
    Date Received
    May 4, 2017
    Date of Event
    March 31, 2017
    Report Date
    May 4, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK921182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - BIOMET ALL POLY PATELLA, CATALOG: 11-150830, LOT: 172020; MAXIM RIGHT FEMUR 70 MM, CATALOG: 140053, LOT: 038470; BIOMET TIBIAL TRAY, CATALOG: 141235, LOT: 824640. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION PROCEDURE DUE TO UNKNOWN REASONS; THE TIBIAL BEARING AND PATELLA WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327798 ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT ¿ BIOMET ALL POLY PAT. BUTTON PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 172020

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R