BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 22872434 · Received August 22, 2025

    Report

    Report Number
    3008021110-2025-00106
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    July 8, 2025
    Report Date
    August 22, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    UDI-DI
    08033390102933
    PMA / PMN Number
    K142139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS, NO PRE-EXISTING ANOMALIES WERE FOUND IN THE 69 ITEMS BELONGING TO THE LOT NUMBER 22AT0NB AND STERILIZATION (B)(4). THIS IS THE FIRST AND ONLY COMPLAINT REGISTERED ON THIS LOT NUMBER. WE TRIED TO CLARIFY WITH THE COMPLAINT SOURCE IF THE DISLOCATION WAS CAUSED BY A SUB-OPTIMAL CHOICE OF THE IMPLANT MADE BY THE SURGEON DURING THE PRIMARY SURGERY, BUT WE WERE UNABLE TO RECOVER THIS INFORMATION. THEREFORE, TAKING INTO ACCOUNT THAT: NO PRE-EXISTING ANOMALIES WERE FOUND BY CHECKING THE MANUFACTURING CHARTS OF THE COMPONENT REMOVED IN THE REVISION SURGERY HEREBY REPORTED THIS IS THE FIRST AND ONLY COMPLAINT REGISTERED ON THIS LOT NUMBER. WE HAVE NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA BASED ON THE AVAILABLE PMS DATA, THE REVISION RATE OF SMR REVERSE LINERS BELONGING TO THE FAMILY PRODUCT CODE 1360.50.XXX - 1361.50.XXX - 1365.50.XXX DUE TO DISLOCATION IS AROUND 0.08%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTION IS REQUIRED FOR THIS SPECIFIC CASE. THE MANUFACTURER WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, DUE TO DISLOCATION. THE SURGEON IMPLANTED A THICKER LINER. THEREFORE, THE ONLY COMPONENT REMOVED AND REPLACED BY A NEW ONE IS THE FOLLOWING: SMR REVERSE LINER +3MM D.40MM (PART CODE 1365.50.815, LOT NUMBER 22AT0NB, STERILIZATION (B)(4). THE OTHER COMPONENTS PREVIOUSLY IMPLANTED WERE LEFT IN SITU: TT AUGM.360 BASEPLATE #S-R+2MM (PART CODE 1375.15.522, LOT NUMBER 2211656, STERILIZATION (B)(4). SMR REVERSE HUMERAL BODY SHORT (PART CODE 1352.15.005, LOT NUMBER 2202509, STERILIZATION (B)(4). SMR GLENOSPHERE Ø 40MM (PART CODE 1374.09.121, LOT NUMBER 2206405, STERILIZATION (B)(4), SMR CONNECTOR SMALL R (PART CODE 1374.15.305, LOT NUMBER 2213086, STERILIZATION (B)(4), SMR GLENOID PEG TT SMALL-R #M (PART CODE 1375.14.652, LOT NUMBER 2213319, STERILIZATION (B)(4). SMR CEMENTLESS FINNED STEM (PART CODE 1304.15.180, LOT NUMBER 2209462, STERILIZATION (B)(4). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1951. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495171 SMR SHOULDER REVERSE LINER 40MM +3MM PHX LIMACORPORATE S.P.A. 1365.50.815 22AT0NB 08033390102933

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention