BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNI GLENOID-PERIPHERAL LOCK SCRW

    MDR report key: 17976800 · Received October 20, 2023

    Report

    Report Number
    1220246-2023-08281
    Event Type
    Injury
    Date Received
    October 20, 2023
    Date of Event
    September 19, 2023
    Report Date
    December 19, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867057753
    PMA / PMN Number
    K142863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-9145-48 UNI GLENOID-PERIPHERAL LOCK SCREW SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE RETURNED DEVICE'S HEX GEOMETRY WAS DAMAGED, MAYBE DUE TO EXCESSIVE TIGHTENING FORCES. THE METHOD OF BONE PREPARATION EMPLOYED DURING THE PROCEDURE, AS WELL AS THE BONE QUALITY ENCOUNTERED, WAS NOT PROVIDED. A CAUSE FOR THE REPORTED FAILURE MAY BE A PATIENT-SPECIFIC EVENT. PER DFU-0189-12 AT REVISION 0. C. CONTRAINDICATIONS. 3. FOREIGN BODY SENSITIVITY. WHERE MATERIAL SENSITIVITY IS SUSPECTED, APPROPRIATE TESTS SHOULD BE MADE, AND SENSITIVITY RULED OUT PRIOR TO IMPLANTATION. 4. ANY ACTIVE INFECTION OR BLOOD SUPPLY LIMITATIONS. D. ADVERSE EFFECTS. 1. INFECTIONS, BOTH DEEP AND SUPERFICIAL. 2. FOREIGN BODY REACTIONS. 7. ALLERGIES AND OTHER REACTIONS TO DEVICE MATERIALS.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN INITIAL SURGERY ON (B)(6) 2023 THE PATIENT DEVELOPED A SEVERE INFECTION WHICH AFFECTED THE PATIENT FOR 6 MONTHS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO REMOVE THE INVOLVED IMPLANTS. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064241 UNI GLENOID-PERIPHERAL LOCK SCRW SHOULDR PROSTH, REVERSE CONFIG PHX ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW 22.00521 00888867057753

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other