BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION KNEE

    MDR report key: 15298313 · Received August 25, 2022

    Report

    Report Number
    1644408-2022-01130
    Event Type
    Injury
    Date Received
    August 25, 2022
    Date of Event
    August 10, 2022
    Report Date
    August 25, 2022
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    JWH
    UDI-DI
    00888912116695
    PMA / PMN Number
    K933539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE: 12/31/2015 (31-DEC-2015). THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS INSTABILITY. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 10 YEARS AND 6 MONTHS APART. INITIAL OR PROLONGED HOSPITALIZATION WAS REQUIRED. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS A SERIOUS RISK 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 DISPOSED OF AT HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THAT THE REPORTED COMPONENT USED IN THE PREVIOUS SURGERY, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WAS NO NON-CONFORMING MATERIAL REPORT (NCMR) ASSOCIATED WITH THE PRODUCT THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE WAS VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WAS WITHIN ITS EXPIRATION DATE AT THE TIME OF THE PREVIOUS SURGERY. CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICE SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT ARE NEEDING A REVIEW. THE ROOT CAUSE OF THIS COMPLAINT WAS A REVISION SURGERY DUE TO INSTABILITY. THERE WERE NO FINDINGS DURING THIS EVALUATION THAT INDICATE THE REPORTED DEVICE WAS DEFECTIVE. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE EVENT. THERE ARE MULTIPLE FACTORS THAT MAY ALSO CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE THE CONTROL OF DJO SURGICAL SUCH AS POOR BONE DENSITY, INADEQUATE SOFT TISSUE SUPPORT, PATIENT ACTIVITIES OR TRAUMA. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    REVISION SURGERY - PATIENT WAS UNSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2560239 FOUNDATION KNEE INSERT, CONSTRAINED, P.S., SIZE6 13MM CM JWH ENCORE MEDICAL L.P. 370-13-506 59601108 00888912116695

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Hospitalization| R| O