BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANCELLOUS SCREWS

    MDR report key: 23579327 · Received November 18, 2025

    Report

    Report Number
    3008021110-2025-00148
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    April 15, 2025
    Report Date
    November 18, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    UDI-DI
    08033390110693
    PMA / PMN Number
    K172456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS INVOLVED IN THIS EVENT, NO PRE-EXISTING ANOMALY WAS DISCOVERED IN THE ITEMS BELONGING TO THE SAME PART CODE AND LOT NUMBER AS THE DEVICES REMOVED IN THE REVISION SURGERY HEREBY REPORTED. THE MANUFACTURER WILL SUBMIT THE FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. DURING REVISION PROCEDURE, THE LINER WAS REMOVED AND EXAMINED (SMR REVERSE LINER STANDARD, PART CODE 1360.50.810, LOT NUMBER 20AT0XN, STERILIZATION (B)(4)), NOT SHOWING SIGNIFICANT OR UNUSUAL SIGNS OF WEAR. THE REVERSE BODY WAS LEFT IN PLACE BECAUSE IT WAS DETERMINED THAT REMOVING WOULD THREATEN TO FRACTURE TUBEROSITIES. GLENOSPHERE (SMR ECCENT. GLENOSPHERE Ø 36MM, PART CODE 1376.09.031, LOT NUMBER 2009277, STERILIZATION (B)(4)) AND BONE SCREWS (BONE SCREW Ø6,5 H.15MM, PART CODE 8420.15.005, LOT NUMBER 1802866, STERILIZATION (B)(4); BONE SCREW Ø6,5 H.20MM, PART CODE 8420.15.010, LOT NUMBER 2006407, STERILIZATION (B)(4); BONE SCREW Ø6,5 H.40MM, PART CODE 8420.15.050, LOT NUMBER 2006421, STERILIZATION (B)(4)) WERE REMOVED. AT THIS POINT, THE BASEPLATE (TT AUGM.360 BASEPLATE #S-R+2MM, PART CODE 1375.15.522, LOT NUMBER 2008603, STERILIZATION (B)(4)) COULD BE PULLED OUT BY HAND WITH HEMOSTATS. DURING REMOVAL OF SCREWS, IT WAS NOTED THAT THERE WERE METAL SHAVINGS (APPARENTLY FROM THE SCREWS) LEFT BEHIND THE BASEPLATE. IT WAS HYPOTHESIZED THAT THIS DEBRIS MAY HAVE BEEN CREATED WHILE IMPLANTING THE SCREWS AT TOO AGGRESSIVE OF AN ANGLE. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2020. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1946. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494459 CANCELLOUS SCREWS BONE SCREWS DIA. 6.5 X H. 15 MM LPH LIMACORPORATE S.P.A. 8420.15.005 1802866 08033390110693

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention