BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION HIP

    MDR report key: 11732020 · Received April 27, 2021

    Report

    Report Number
    1644408-2021-00324
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    March 30, 2021
    Report Date
    May 31, 2021
    Manufacturer
    ENCORE MEDICAL LP
    Product Code
    JWH
    UDI-DI
    00888912117838
    PMA / PMN Number
    K000590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS INSTABILITY AND WARE. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 5 YEARS AND 9 MONTHS APART. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS 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 DEVICES WERE DISPOSED OF AT HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOW THAT THE REPORTED COMPONENTS USED IN THE PREVIOUS SURGERY, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NON-CONFORMING MATERIAL REPORTS (NCMR) ASSOCIATED WITH THE PRODUCTS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICES WERE VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WERE WITHIN ITS EXPIRATION DATE AT THE TIME OF THE PREVIOUS SURGERY. CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICES 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 AND WARE. THERE WERE NO FINDINGS DURING THIS EVALUATION THAT INDICATE THE REPORTED DEVICES WERE 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, PATIENT BONE DETERIORATION, 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 AS SOON AS IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT HAD INSTABILITY. SURGEON WENT FROM AN 11MM POLY TO 15MM. HE ALSO REPLACED THE PATELLA BECAUSE OF WARE ON ORIGINAL POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628981 FOUNDATION HIP INSERT, STD., PRIMARY, SIZE4 11MM CM JWH ENCORE MEDICAL LP 385-11-504 491B1037 00888912117838

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R 130-03-026 LOT 473A1009| 130-03-026 LOT 473A1009