BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO SURGICAL

    MDR report key: 23089033 · Received September 18, 2025

    Report

    Report Number
    1644408-2025-01363
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    August 22, 2025
    Report Date
    February 12, 2026
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    PHX
    UDI-DI
    00888912024747
    PMA / PMN Number
    K051075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AGENT REPORTED BASEPLATE AND PERIPHERAL SCREWS WERE IMPLANTED. AFTER SEVERAL ATTEMPTS THE GLENOSPHERE WAS SEATED CORRECTLY. THE SECONDARY IMPACTOR WAS USED. DURING THE PLACEMENT/INSERTION OF THE STAINING SCREW IT WAS NOTICED THAT IT WOULD NOT "DROP IN" AND COULD NOT BE TIGHTENED. AFTER SEVERAL ATTEMPTS IT WAS DETERMINED THAT THE SCREW WOULD NOT SEAT CORRECTLY. THE SCREW WAS EXAMINED AND THE GLENOSPHERE WAS REMOVED. UPON A SECOND ATTEMPT TO PLACE SCREW WITH NO SUCESS, A STAND-ALONE RETAINING SCREW WAS USED WITH NO SUCCESS. THE GLENOSPHERE WAS REMOVED AND BROUGHT TO THE BACK TABLE, WHERE IT WAS SHOWN THAT THE RETAINING SCREW WOULD "DROP IN". IT WAS DETERMINED TO IMPLANT A NEW BASEPLATE. THE ORIGINAL GLENOSPHERE AND THE NEW RETAINING SCREW WERE ATTEMPTED TO BE IMPLANTING, WITH THE SAME RESULTS: IE THE SCREW WOULD NOT SEAT. IT WAS DETERMINED TO USE ANOTHER GLENOSPHERE WITH THE RETAINING SCREW INCLUDED WITH THE NEW GLENOSPHERE, WHICH WORKED SUCCESSFULLY. 68 YR OLD FEMALE." RMA EXAMINATION: THE REPORTED DEVICE(S) WAS RETURNED TO SURGICAL AND EXAMINATION OF THE RETAINING SCREWS SHOWED SIGNS OF USE WITH DAMAGE TO THE THREADS. THIS EVENT OCCURRED DURING SURGERY NEAR THE PATIENT. THE COMPONENTS WERE INSPECTED PRIOR TO SURGERY AND FOUND ACCEPTABLE. THERE WAS ANOTHER SUITABLE DEVICE AVAILABLE, HOWEVER, THE INCIDENT DID CAUSE A 24 MIN. DELAY IN SURGERY. THERE WAS NO RISK OR ADVERSE EVENT REPORTED, AND THE SURGERY WAS COMPLETED AS INTENDED. SURGICAL COMPONENTS CONDITION CAN BE DETERMINED WHILE BEING USED FOR ITS INTENDED PURPOSE. THIS DOES NOT INDICATE A PRODUCT DEFICIENCY, FAILURE, OR ISSUE. NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWS THAT THE REPORTED COMPONENT, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NONCONFORMING MATERIAL REPORTS ASSOCIATED WITH THE PRODUCT(S) THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. COMPLAINT DATABASE REVIEW SHOWED NO PREVIOUS COMPLAINTS AGAINST ITEM (B)(4) LOT NO. 864C7620, ACROSS ALL FAILURE CODE CATEGORIES. INVENTORY CONTAINMENT IS NOT REQUIRED AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE ROOT CAUSE OF THIS COMPLAINT IS LIKELY ATTRIBUTABLE TO INCORRECT USE. IT IS PLAUSIBLE THAT THE DEVICE WAS HELD AT AN INCORRECT ANGLE WHICH LED TO THE ISSUE. THIS IS AN EVENT ASSOCIATED WITH ERROR WHEN USED, NOT AN EVENT ASSOCIATED WITH PRODUCT FAILURE OR MALFUNCTION.

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION IS COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BASEPLATE AND PERIPHERAL SCREWS WERE IMPLANTED, AND AFTER SEVERAL ATTEMPTS, THE GLENOSPHERE WAS CORRECTLY SEATED USING THE SECONDARY IMPACTOR. DURING INSERTION OF THE RETAINING SCREW, IT WAS NOTED THAT THE SCREW WOULD NOT "DROP IN" OR TIGHTEN. MULTIPLE ATTEMPTS WERE UNSUCCESSFUL, INCLUDING USE OF A STAND-ALONE RETAINING SCREW. THE GLENOSPHERE WAS REMOVED AND INSPECTED; THE SCREW WAS ABLE TO "DROP IN" ON THE BACK TABLE. A NEW BASEPLATE WAS IMPLANTED, BUT SIMILAR ISSUES OCCURRED WHEN REATTEMPTING WITH THE ORIGINAL GLENOSPHERE AND NEW SCREW. ULTIMATELY, A NEW GLENOSPHERE WITH ITS INCLUDED RETAINING SCREW WAS USED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2835844 DJO SURGICAL GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/-4MM PHX ENCORE MEDICAL L.P. 864C7620 00888912024747

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female 508-32-204 LOT CODE 769P3805