BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PKS MEN BEARING UHMWPE SMALL SZ 3

    MDR report key: 2945484 · Received February 6, 2013

    Report

    Report Number
    3002806535-2013-00015
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    April 30, 2012
    Report Date
    January 9, 2013
    Manufacturer
    .
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. MANUFACTURE DATE - UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE RETRIEVED OXFORD BEARING HAS CLEAR EVIDENCE OF HIGH WEAR, WHICH COULD PROBABLY IN PART BE ATTRIBUTED TO THIRD BODY DAMAGE, INCONGRUENT ARTICULATION AND IMPINGEMENT. IT SEEMS PLAUSIBLE THAT SUCH RESULTING HIGH WEAR LED TO ELEVATED AND ABNORMAL STRESSES, AND SUBSEQUENT OXIDATION, EMBRITTLEMENT AND FATIGUE OF THE POLYETHYLENE, TO THE POINT OF FRACTURE OF THE PART. USING THE EVIDENCE SUPPLIED, IT IS CLEAR THAT THE FAILURE PROCESS OF THE RETRIEVED BEARING WAS MULTI-FACTORIAL. MDR REPORT #1825034-2012-00672 WAS ALSO SUBMITTED BY BIOMET ORTHOPEDICS FOR THIS EVENT BEFORE IT WAS DISCOVERED THE ITEM WAS MANUFACTURED IN BIOMET (B)(4). THAT MDR REPORT SHOULD BE DISREGARDED AS IT IS A DUPLICATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY SURGERY ON (B)(6) 2005. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO BEARING FRACTURE. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51291 OXFORD PKS MEN BEARING UHMWPE SMALL SZ 3 OXFORD TIBIAL BEARING NRA . N/A 813925

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R