BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUREPAIR

    MDR report key: 2497799 · Received March 21, 2012

    Report

    Report Number
    1219602-2012-00057
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    January 31, 2012
    Report Date
    February 21, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    MQV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIV.; IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR 803, THE MDR REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW INC. ENDOSCOPY DIV. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. NO PRODUCT IS BEING RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    (B)(4) HAD A RE-OPERATION ON (B)(6) (1 YEAR POST-OP) DURING WHICH TIME THEIR TRUFIT IMPLANTS WERE REMOVED DUE TO PAIN, POOR MOBILITY AND ON BONE SCAN HIGH ACTIVITY MEDIAL COMPARTMENT (MEDIAL ARTHRITIS). DURING THE SAME OPERATION HE RECEIVED A HEMI OXFORD MEDIAL KNEE. SUBJECT HAD BEEN RANDOMIZED TO TRUFIT 6 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUREPAIR TRUFIT CB PLUG, PURPLE, 11MM MQV SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 72200936 50351565

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention