BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION KNEE

    MDR report key: 4132870 · Received October 1, 2014

    Report

    Report Number
    1644408-2014-00601
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K963028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO ALLEVIATE PATIENT KNEE COLLATERAL LIGAMENT LAXITY OF UNKNOWN ORIGIN. THE LENGTH OF TIME IN-VIVO IS UNKNOWN SINCE NO ORIGINAL SURGERY DATE WAS PROVIDED OR DETERMINED. THE INFORMATION PROVIDED WITH THE INVESTIGATION SUGGESTS THE IMPLANT MAY HAVE BEEN IN VIVO APPROXIMATELY 8 YEARS. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, OR ACCIDENTS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS LEFT IN THE PATIENT AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS AND INVESTIGATION HISTORY WAS NOT CONDUCTED SINCE A LOT NUMBER WAS NOT PROVIDED OR COULD BE ESTABLISHED FOR THE ORIGINAL SURGERY. MULTIPLE SEARCHES OF THE PATIENT DATABASE COULD NOT CONFIRM A PART/LOT NUMBER OR ANY INFORMATION IDENTIFYING THE DATE OF THE ORIGINAL SURGERY. INFORMATION WAS NOT PROVIDED THAT DEFINITIVELY IDENTIFIED A ROOT CAUSE FOR THE LAXITY. FACTORS UN-RELATED TO THE IMPLANTS THAT MAY CONTRIBUTE TO A LAXITY ARE: DEGENERATIVE TISSUE, IMPROPER SURGICAL TECHNIQUE OR INCORRECT IMPLANT SELECTION. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Additional Manufacturer Narrative · 1

    DEVICE LEFT IN PATIENT.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO COLLATERAL LIGAMENT LAXITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613245 FOUNDATION KNEE FOUNDATION ULTRA-CONGRUENT INSERT 11MM CM 4 JWH ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R