BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERFILL HIP

    MDR report key: 12012132 · Received June 16, 2021

    Report

    Report Number
    1644408-2021-00586
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    May 26, 2021
    Report Date
    July 1, 2021
    Manufacturer
    ENCORE MEDICAL LP
    Product Code
    LPH
    UDI-DI
    00888912078665
    PMA / PMN Number
    K130099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS FRACTURE AFTER A FALL. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 23 DAYS APART. THE HEALTHCARE PROFESSIONAL INDICATED 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 WAS AN (B)(4) ASSOCIATED WITH THE MAIN PART # 425-97-008, TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 8, WHICH DOCUMENTS THAT OUT OF 12 PARTS LOT, ALL WERE REJECTED DUE TO FURNACE BLEW FUSE, SHUT OFF. LATER THE REJECTED PARTS WERE USED AS IS AFTER PROPER JUSTIFICATION. 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 FRACTURE AFTER A FALL. 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. AGENT HAS CLEARLY MENTIONED THAT "PATIENT FELL" AND ALSO DUE TO THE SHORT TIME BETWEEN THE PREVIOUS AND THE REVISION SURGERY, IT IS POSSIBLE THAT THE EVENT MAY HAVE OCCURRED DUE TO LACK OF POST-OPERATIVE CARE, PATIENT NONCOMPLIANCE WITH MEDICAL INSTRUCTIONS, IMPROPER IMPLANT SELECTION, PATIENT ACTIVITIES OR TRAUMA. THERE ARE MULTIPLE FACTORS THAT MAY ALSO CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE THE CONTROL OF DJO SURGICAL. 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 - PATIENT FELL AND FRACTURED HIS FEMUR A COUPLE OF WEEKS AFTER HIS INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905536 TAPERFILL HIP TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 8 LPH ENCORE MEDICAL LP 425-97-008 173R1244 00888912078665

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 400-03-362 LOT 866B1638.