BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER SYSTEM

    MDR report key: 24207499 · Received January 29, 2026

    Report

    Report Number
    3008021110-2026-00116
    Event Type
    Injury
    Date Received
    January 29, 2026
    Report Date
    January 29, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    UDI-DI
    08033390152112
    PMA / PMN Number
    K183042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS, NO PRE-EXISTING ANOMALY WAS DISCOVERED IN THE ITEMS BELONGING TO THE SAME PRODUCT CODES AND LOT NUMBERS AS THOSE OF THE COMPONENTS INVOLVED IN THIS EVENT. THE MANUFACTURER WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    ON (B)(6) 2019, PATIENT HAD LEFT REVERSE TOTAL SHOULDER. ON (B)(6) 2020, PATIENT DISLOCATED SHOULDER FOR THE FIRST TIME. WHEN VISITING THE LOCAL URGENT CARE, THE SHOULDER COULD NOT BE REDUCED. PATIENT FELL ASLEEP AND SOMEHOW HIS SHOULDER REDUCED. X-RAY REVEALS A WELL REDUCED REVERSE TSA, NO FX'S. THE DOCTOR NOTES: "IF HE DISLOCATES AGAIN, WE WILL HAVE TO CONSIDER A CONSTRAINED LINER WITH OR WITHOUT AN EXTENSION." ON (B)(6) 2020, VISIT THE DOCTOR NOTES "HE APPEARS TO HAVE TORN HIS SUBSCAPULARIS", WHICH HE STATES, "THERE IS NO REASON TO GO BACK AND DO ANYTHING". DURING ON (B)(6) 2022 VISIT, THE DOCTOR NOTED THE FOLLOWING: "HE HAS HAD 2 ADDITIONAL EPISODES OF SUBLUXATION/DISLOCATION. THE MOST RECENT WAS ON (B)(6) 2021, WHICH HE WAS ABLE TO REDUCE ON HIS OWN." TREATMENT OPTIONS WERE DISCUSSED, AND THE DOCTOR REQUESTED A CUSTOM-MADE DEVICE 44MM ALL POLY GLENOSPHERE. DOCTOR ALSO MENTIONS "POSSIBILITY OF AN INFECTION". CULTURES WERE SENT BUT THE MANUFACTURED DID NOT RECEIVE THE OUTCOME. THE COMPONENTS INVOLVED IN THIS EVENT ARE THE FOLLOWING: SMR SMALL-R CONNECTOR +4 (PART CODE: 1374.15.314, LOT NUMBER: 1915239, STERILIZATION: 1900342) SMR METAL-BACK GLENOID SMALL R (PART CODE: 1375.21.005, LOT NUMBER: 1915286, STERILIZATION: 1900396). THE DATE OF THE REVISION SURGERY IS CURRENTLY UNKNOWN. THE PATIENT IS A MALE, DATE OF BIRTH ON (B)(6) 1955. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272164 SMR SHOULDER SYSTEM CONNECTOR LAT +4 MM + SCREW - SMALL-R KWS LIMACORPORATE S.P.A. 1374.15.314 1915239 08033390152112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other