BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT-PATELLA

    MDR report key: 6513122 · Received April 21, 2017

    Report

    Report Number
    0001825034-2017-02729
    Event Type
    Injury
    Date Received
    April 21, 2017
    Report Date
    July 29, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK921182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). MEDICAL PRODUCT-BIOMET CC CRUCIATE TRAY 83MM CATALOG# 141236 LOT# 715600, ASCENT PRI LIP BRG 10X79/83 CATALOG# 179330 LOT# 772410, ASCENT PRI INLK FMRL MED RT CATALOG# 179003 LOT# 704930. 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 - 02689, 0001825034 - 2017 - 02728, 0001825034 - 2017 - 02729 , 0001825034 - 2017 - 02731.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293406 ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT-PATELLA PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 596640

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10 NARRATIVE