BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SYSTEM

    MDR report key: 16945189 · Received May 17, 2023

    Report

    Report Number
    3008021110-2023-00052
    Event Type
    Injury
    Date Received
    May 17, 2023
    Date of Event
    July 4, 2018
    Report Date
    March 25, 2025
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    PHX
    UDI-DI
    08033390272216
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALIES WAS DETECTED ON THE PIECES MANUFACTURED WITH THE INVOLVED LOT NUMBERS (15AT1H5, 1713817). ACCORDING TO THE PMS DATA AT LEAST (B)(4) PIECES SMR GLENOSPHERE Ø36MM SMALL-R MANUFACTURED WITH LOT 1713817 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. ACCORDING TO THE PMS DATA AT LEAST (B)(4) PIECES SMR REV. LINER RETENTIVE +6 MM MANUFACTURED WITH LOT 15AT1H5 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. THE EXPLANTED DEVICES WERE NOT RETURNED TO LIMACORPORATE FOR FURTHER INVESTIGATION. LIMACORPORATE RECEIVED ONLY PRE-OPERATIVE X-RAYS OF REVISION SURGERY. THE AVAILABLE INFORMATION AND X-RAYS HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THERE MUST HAVE BEEN SOME SORT OF INFECTION, THAT LED TO THE REVISION WHICH WAS TREATED BY REMOVAL AND CEMENT SPACER IMPLANTATION. THE FOLLOWING SURGERIES SHOW A REDUCED BONE STOCK AT THE PROXIMAL HUMERUS WITH REDUCED PARTS OF THE METAPHYSIS. THIS MAY HAVE LED TO REDUCED COMPRESSION STRENGTH TO THE REVISION IMPLANT THAT THEN LED TO DISLOCATION. ANYWAY, THERE ARE NO SIGNS OF IMPLANT-RELATED PROBLEMS THAT LED TO THE REVISIONS.". BASED ON THE AVAILABLE INFORMATION, WE CANNOT DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT. CONSIDERING THAT: · THE CHECK OF THE DEVICE HISTORY RECORDS REVEALED NO PRE-EXISTING ANOMALIES IN THE INVOLVED LOT NUMBERS · THE EXPLANTED DEVICES WERE NOT RETURNED TO LIMACORPORATE FOR FURTHER INVESTIGATION · ACCORDING TO THE MEDICAL CONSULTANT, THE REDUCED BONE STOCK IN THE PROXIMAL HUMERUS MAY HAVE WEAKENED THE IMPLANT'S COMPRESSION STRENGTH, LEADING TO DISLOCATION, WITH NO SIGNS OF IMPLANT-RELATED ISSUES. WE MAY CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA THE REVISION RATE OF SMR REVERSE DUE TO DISLOCATION/LUXATION IS NEARLY (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. THIS IS THE FINAL MDR REPORT.

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE EXISTING ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT WAS DETECTED ON THE INVOLVED LOT NUMBERS (15AT1H5, 1713817). WE WILL SUBMIT A FINAL REPORT AFTER THE FINAL INVESTIGATION.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2018: ROUTINE POST OP X-RAYS REVEALED A SUBLUXED HUMERAL PROSTHESIS. THE GLENOSPHERE WAS UPSIZED TO A 40 MM GLENOSPHERE. DURING THIS REVISION SURGERY, THE FOLLOWING DEVICES WERE EXPLANTED: - SMR REV. LINER RETENTIVE +6 MM CODE 136150020, LOT 15AT1H5. - SMR GLENOSPHERE Ø36MM SMALL-R CODE 137409105, LOT 1713817. THE PREVIOUS SURGERY WAS CARRIED OUT ON (B)(6) 2018 AND IT WAS A REVISION SURGERY. (REGISTERED AS COMPLAINT 153/23, NOT REPORTED TO FDA AS THE INVOLVED PRODUCT IS NOT MARKETED IN THE US). THE COMPLAINT SOURCE REPORTED POOR MUSCLE CONTROL AFTER CEMENT SPACER FOR SEVERAL MONTHS AND INSTABILITY WITH THE 36 MM LONG RETENTIVE LINER. THIS EVENT OCCURRED IN THE UNITED KINGDOM. NOTE: THE PRODUCT CODE 136150020 IS NOT MARKETED IN THE US.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2018: ROUTINE POST OP X-RAYS REVEALED A SUBLUXED HUMERAL PROSTHESIS. THE GLENOSPHERE WAS UPSIZED TO A 40 MM GLENOSPHERE. DURING THIS REVISION SURGERY, THE FOLLOWING DEVICES WERE EXPLANTED: SMR REV. LINER RETENTIVE +6 MM CODE 136150020, LOT 15AT1H5 . SMR GLENOSPHERE Ø36MM SMALL-R CODE 137409105, LOT 1713817 . THE PREVIOUS SURGERY WAS CARRIED OUT ON (B)(6) 2018 AND IT WAS A REVISION SURGERY (REGISTERED AS COMPLAINT 153/23, NOT REPORTED TO FDA AS THE THE INVOLVED PRODUCT IS NOT MARKETED IN THE US). THE COMPLAINT SOURCE REPORTED POOR MUSCLE CONTROL AFTER CEMENT SPACER FOR SEVERAL MONTHS AND INSTABILITY WITH THE 36 MM LONG RETENTIVE LINER. THIS EVENT OCCURRED IN THE UNITED KINGDOM. NOTE: THE PRODUCT CODE 136150020 IS NOT MARKETED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054028 SMR SYSTEM GLENOSPHERE - SMALL-R PHX LIMACORPORATE S.P.A 1374.09.105 1713817 08033390272216

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention