BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 21932842 · Received April 30, 2025

    Report

    Report Number
    3008021110-2025-00039
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    March 11, 2025
    Report Date
    April 30, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    UDI-DI
    08033390080620
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CHECKING THE MANUFACTURING CHARTS OF THE DEVICES INVOLVED, NO PRE-EXISTING ANOMALY WAS DISCOVERED ON THE ITEMS BELONGING TO THE SAME PART CODES AND LOT NUMBERS AS THE COMPONENTS REMOVED. WE HAVE NOT RECEIVED ANY ADDITIONAL INFORMATION FROM THE COMPLAINT SOURCE, SUCH AS REMOVED DEVICES OR RADIOGRAPHS; THEREFORE, WE CANNOT INVESTIGATE FURTHER THE EVENT. HOWEVER, ACCORDING TO THE SURGEON'S REMARKS RECEIVED, NO RISK OR ADVERSE EVENT OCCURRED. THUS, CONSIDERING THAT: NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED ON THE ITEMS BELONGING TO THE SAME PART CODES AND LOT NUMBERS AS THOSE INVOLVED IN THE EVENT. ACCORDING TO THE SURGEON'S COMMENT, THERE WAS NO RISK OR ADVERSE EVENT. WE HAVE NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA: ACCORDING TO THE RELEVANT PMS DATA, THE REVISION RATE OF THE SMR REVERSE LINERS BELONGING TO THE FAMILY PRODUCT CODES: 1360.50.XXX + 1361.50.XXX + 1365.50.XXX DUE TO INSTABILITY IS AROUND 0.017%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTION IS REQUIRED FOR THIS SPECIFIC CASE. THE MANUFACTURING 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 PERFORMED ON (B)(6) 2025 DUE TO INSTABILITY. THE PATIENT HAD A REVERSE SHOULDER ARTHROPLASTY WITH A 140° REVERSE BODY, +3MM LINER, AND A 36 GLENOSPHERE WITH A +2 ADAPTOR. THE PATIENT HAD STABILITY ISSUES AND WAS TAKEN BACK TO INCREASE LINER HEIGHT AND GLENOSPHERE LATERALIZATION TO +6MM LINER AND +4MM ADAPTER. THEREFORE, THE FOLLOWING COMPONENTS WERE REMOVED: SMR REVERSE LINER + 3 MM (PART CODE: 1360.50.815, LOT NUMBER: 23AT252, STERILIZATION 2400011). SMR GLENOSPHERE DIA. 36MM (PART CODE: 1374.09.111, LOT NUMBER: 2114595, STERILIZATION 2100307). SMR SMALL-R CONNECTOR +2 (PART CODE: 1374.15.312, LOT NUMBER: 2333194, STERILIZATION 2400017). THE ABOVE-MENTIONED DEVICES WERE REPLACED WITH THE FOLLOWING NEW ONES: SMR GLENOSPHERE DIA. 36MM (PART CODE: 1374.09.111, LOT NUMBER: 2402557, STERILIZATION 2400067). SMR SMALL-R CONNECTOR LAT. +4 (PART CODE: 1374.15.314, LOT NUMBER: 2412565, STERILIZATION 2400123). SMR REVERSE LINER +6 MM (PART CODE: 1360.50.820, LOT NUMBER: 23AT254, STERILIZATION 2300190). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2024. THE PATIENT IS A FEMALE, 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
    1581671 SMR SHOULDER REVERSE LINERS 36MM (UHMWPE) +3MM PHX LIMACORPORATE S.P.A. 1360.50.815 23AT252 08033390080620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention