BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMPOWR HIP

    MDR report key: 15365306 · Received September 6, 2022

    Report

    Report Number
    1644408-2022-01178
    Event Type
    Injury
    Date Received
    September 6, 2022
    Date of Event
    August 29, 2022
    Report Date
    September 6, 2022
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    LPH
    UDI-DI
    00190446309772
    PMA / PMN Number
    K190057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE: 03/29/2027 (29-MAR-2027). THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS DEVELOPMENT OF SEROMA IN HIP. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 3 MONTHS 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 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 DEVELOPMENT OF SEROMA IN HIP. 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. 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 DEVELOPED SOME SORT OF SEROMA IN HIS HIP. IRRIGATION AND DRAINAGE WAS DONE WITH HEADLINER EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2852053 EMPOWR HIP EMPOWR ACETABULAR SYSTEM, LINER, 10° HOODED, HXE+, 36G LPH ENCORE MEDICAL L.P. 942-01-36G 623Z1063 00190446309772

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention 400-03-363 LOT 868B1418