BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXFORD TRIAL BEARING MED SZ 3

    MDR report key: 7503541 · Received May 10, 2018

    Report

    Report Number
    3002806535-2018-00789
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Date of Event
    April 16, 2018
    Report Date
    March 8, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE QUALITY ENGINEER FOR INVESTIGATION. THE DHR FOR THE INVOLVED PRODUCT HAS BEEN REVIEWED AND DOES NOT SHOW ANY NON-CONFORMITY, REJECTION OR CONCESSION THAT COULD BE RELATED TO THE REPORTED EVENT. SOME SCRATCHES WERE FOUND ON THE ARTICULATING SURFACES. DAMAGE TO THE THREAD WAS OBSERVED, WHERE THE HANDLE IS NORMALLY ASSEMBLED. A FRAGMENT WAS MISSING FROM BELOW THE THREADED HOLE, LIKELY DUE TO STRESSES CONCENTRATING IN THE AREA AND CONSEQUENT FATIGUE OVER MULTIPLE USES. CONSIDERING THE FACT THAT THE FRACTURED TRIAL BEARING WAS A PHASE 3 OXFORD PARTIAL KNEE INSTRUMENT, WHICH HAS BEEN COMMERCIALLY AVAILABLE SINCE 1998, FAILURE OF THE COMPONENT COULD BE ASCRIBED TO NORMAL WEAR AND DAMAGE DUE TO USE.

    Description of Event or Problem · 0

    OXFORD TRIAL BEARING BROKE FROM THE HANDLE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE TRIAL BROKE FROM THE HANDLE. THE EVENT OCCURRED DURING SURGERY. THEY USED THERE SECOND TRIAL TO PERFORM THE SURGERY. THERE WAS NO INJURY TO THE PATIENT, BODY OR HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347402 OXFORD TRIAL BEARING MED SZ 3 HRY BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1