BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNICOMPARTMENTAL KNEE PHASE 3 ANATOMIC ARCOM MENISCAL BEARING

    MDR report key: 2180352 · Received July 27, 2011

    Report

    Report Number
    1825034-2011-00648
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BIOMET UK LTD
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED COMPONENT FOUND THE ARTICULATING SURFACE HAS SCRATCHES, PITS AND GOUGES. THIS WEAR IS CONSISTENT WITH FOREIGN PARTICLE DEBRIS WEAR. THE POSTERIOR RIM OF THE BEARING HAS PARALLEL ABRASIONS WHICH MAY HAVE BEEN CAUSED BY FOREIGN PARTICLE DEBRIS OR DELAMINATION DUE TO OXIDATION. THIS REPORT FILED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." DATE IMPLANTED - 2008; EXACT DATE UNKNOWN. NO PRODUCT IDENTIFICATION WAS RECEIVED ON THE POLY BEARING IMPLANTED IN 2007. SHOULD INFORMATION BE RECEIVED INCLUDING PRODUCT PRODUCT IDENTIFICATION, AN ADDITIONAL MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE USER FACILITY WAS NOTIFIED OF THE EVENTS ON (B)(4), 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE LEFT PARTIAL KNEE ARTHROPLASTY IN 2007 AND THAT A REVISION PROCEDURE WAS PERFORMED IN 2008 TO REMOVE THE POLY BEARING DUE TO WEAR. PATIENT FURTHER REPORTED THAT A SUBSEQUENT REVISION WAS PERFORMED TO REMOVE THE POLY BEARING THAT WAS IMPLANTED IN 2008. ADDITIONAL INFORMATION OBTAINED REVEALED THAT THE SUBSEQUENT REVISION PROCEDURE OCCURRED ON (B)(6) 2011 DUE TO DISLOCATION. THE POLY BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD UNICOMPARTMENTAL KNEE PHASE 3 ANATOMIC ARCOM MENISCAL BEARING PROSTHESIS, KNEE NRA BIOMET UK LTD N/A 545742

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R