BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 22517532 · Received July 16, 2025

    Report

    Report Number
    3008021110-2025-00091
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    May 29, 2025
    Report Date
    July 16, 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

    INVESTIGATION CHECKING THE MANUFACTURING CHARTS OF THE REMOVED DEVICES, NO PRE-EXISTING ANOMALY WAS FOUND OUT ON: THE (B)(4) ITEMS BELONGING TO THE PART NUMBER: 1365.50.815 AND LOT: 23AT40L. THE (B)(4) ITEMS BELONGING TO THE PART NUMBER: 1976.09.040 AND LOT: 2316007. THE (B)(4) ITEMS BELONGING TO THE PART NUMBER: 1974.15.302 AND LOT: 2312609. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ABOUT THESE BATCH NUMBERS. WE DID NOT RECEIVE ANY ADDITIONAL INFORMATION (X-RAY, PATIENT'S CLINICAL INFORMATION OR PICTURES OF THE REMOVED DEVICES) AND THE EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER. WE HAVE BEEN INFORMED THAT THE REMOVED DEVICES WERE REPLACED BY THE FOLLOWING ITEMS: PRIMA TT GLENOID ECC. GLENOSPHERE (PART CODE: 1976.09.040, LOT NUMBER: 2219614, STERILIZATION: 2200277). PRIMA TT GLENOSPHERE CONNECTOR WITH SCREW (PART CODE: 1974.15.304, LOT NUMBER: 2221521, STERILIZATION: 2200310). SMR EXTENSION FOR HUMERAL REVERSE BODY (PART CODE: 1352.15.001, LOT NUMBER: 2219904, STERILIZATION: 2200266). SMR REVERSE LINER +6MM DIA=40MM (PART CODE: 1365.50.820, LOT NUMBER: 24AT3VE, STERILIZATION: 2500003). HENCE, CONSIDERING THAT: NO PRE-EXISTING ANOMALY WAS FOUND OUT BY CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS REMOVED DURING THE REVISION SURGERY HEREBY REPORTED. WE HAVE NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA: ACCORDING TO THE AVAILABLE PMS DATA, THE REVISION RATE OF SMR REVERSE LINERS BELONGING TO THE FAMILY PRODUCT CODES: 1360.50.XXX, 1361.50.XXX AND 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 FOLLOWING COMPONENTS PREVIOUSLY IMPLANTED WERE REMOVED AND REPLACED BY OTHER NEW COMPONENTS: SMR REVERSE LINER +3MM D.40MM (PART CODE: 1365.50.815, LOT NUMBER: 23AT40L, STERILIZATION: 2400045). CONNECTOR W. SCREW MED.LAT.7MM (PART CODE: 1974.15.302, LOT NUMBER: 2312609, STERILIZATION: 2300145). GLENOSPH.ECC. D.40MM ECC.4MM (PART CODE: 1976.09.040, LOT NUMBER: 2316007, STERILIZATION: 2300189). THE OTHER COMPONENTS PREVIOUSLY IMPLANTED WERE LEFT IN SITU: BASEPLATE D.25MM REGULAR (PART CODE: 1975.14.500, LOT NUMBER: 2405523, STERILIZATION: 2400083). SMR FINNED SHORT STEM D.21 (PART CODE: 1304.15.021, LOT NUMBER: 1917009, STERILIZATION: 2000019). SMR REVERSE HUMERAL BODY (PART CODE: 1352.15.010, LOT NUMBER: 2412894, STERILIZATION: 2400129). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2024. THE PATIENT IS A MALE, DATE OF BIRTH ON (B)(6) 1957. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555060 SMR SHOULDER REVERSE LINER 40MM +3MM PHX LIMACORPORATE S.P.A. 1365.50.815 23AT40L 08033390102933

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention