BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE LINER RETENTIVE

    MDR report key: 16066770 · Received December 29, 2022

    Report

    Report Number
    3008021110-2022-00139
    Event Type
    Injury
    Date Received
    December 29, 2022
    Date of Event
    December 29, 2022
    Report Date
    February 13, 2024
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    PHX
    PMA / PMN Number
    K142139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COUPLING BETWEEN SMR ECCENT. GLENOSPHERE Ø 40MM, COMMERCIAL CODE 1376.09.041 AND SMR SMALL-R CONNECTOR +4, COMMERCIAL CODE 1374.15.314 IS OFF LABEL USE. THE PRODUCT LABEL FOR 1374.15.314 STATES "COUPLE ONLY WITH CONCENTRIC 36MM DIA OR 40MM GLENOSPHERE. DO NOT USE WITH ECCENTRIC GLENOSPHERE". CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S, NO X RAYS WERE PROVIDED. BASED ON THE INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT. · THE CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S, · THE COUPLING BETWEEN SMR ECCENT. GLENOSPHERE Ø 40MM, COMMERCIAL CODE 1376.09.041 AND SMR SMALL-R CONNECTOR +4, COMMERCIAL CODE 1374.15.314 IS OFF LABEL USE. WE CAN SUPPOSE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA. ACCORDING TO OUR PMS DATA, WE CAN ESTIMATE THE REVISION RATE OF SMR REVERSE LINERS, COMMERCIALS CODES 1360.50.XXX + 1361.50.XXX + 1365.50.XXX FOR DISLOCATION IS 0.06% 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. NOTE: THIS IS THE FINAL MDR.

    Additional Manufacturer Narrative · 0

    WE WILL SEND A FINAL INCIDENT REPORT ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 0

    (B)(6) 2022, FOLLOW UP VISIT THE PATIENT PRESENTED WITH SHOULDER DISLOCATION AND PAIN. SMR REVISION SURGERY IS PLANNED FOR A LATER DATE. REVISION SURGERY WAS PERFORMED ON (B)(6) 2023.PATIENT - MALE.DATE OF BIRTH - (B)(6) 1964.EVENT HAPPENED IN US. IMPLANTS (NOT EXPLANTED)SMR ECCENT. GLENOSPHERE Ø 40MM, COMMERCIAL CODE 1376.09.041 - LOT #2201497 -STER. #2200030SMR REVERSE LINER RETENTIVE, COMMERCIAL CODE 1365.50.816 - LOT #19AT0WE - STER. #1900291SMR SMALL-R CONNECTOR +4, COMMERCIAL CODE 1374.15.314 - LOT #2215813 - STER. #2200201.ACCORDING TO THE COMPLAINT SOURCE, PATIENT HAS A VERY COMPLICATED CLINICAL HISTORY:(B)(6) 2022, REVISION SURGERY PERFORMED FOR DISLOCATION. SURGEON STATED VERY DIFFICULT SURGERY DUE TO PATIENT CONDITION.(B)(6) 2022, PATIENT PRESENTED WITH DISLOCATION AND OPEN REDUCTION WAS PLANNED.(B)(6) 2022, REVISION SURGERY PERFORMED FOR DISLOCATION. THE OPEN REDUCTION WITH FRACTURE REPAIR WAS COMPLETED SUCCESSFULLY. THIS EVENT WAS REGISTERED AS LIMACORPORATE COMPLAINT (B)(4) AND REPORTED TO FDA AS MFR 3008021110-2022-00111. (B)(6) 2022, REVISION SURGERY PERFORMED FOR DISLOCATION/LOOSENING. DURING THE REVISION SURGEON COMMENTED HE OPTED FOR A STANDARD GLENOSPHERE TO BE IMPLANTED BUT THE IDEAL COMPONENT TO BE IMPLANTED WOULD HAVE BEEN A COMPASSIONATE USE DEVICE COMPONENT. (HP REVERSE GLENOSPHERE). THIS EVENT WAS REGISTERED AS LIMACORPORATE COMPLAINT (B)(4) AND REPORTED TO FDA AS MFR 3008021110-2022-00110.(B)(6) 2022, FOLLOW UP VISIT THE PATIENT PRESENTED WITH A DISLOCATION AND PAIN. REVISION SURGERY IS PLANNED FOR A LATER DATE. (OBJECT OF THIS REPORT).(B)(6) 2023, A COMPASSIONATE USE CUSTOM MADE SHOULDER IMPLANT SURGERY WAS PERFORMED. (PER REQUEST FROM (B)(6) 2022, EXAMINATION).(B)(6) 2023, REVISION SURGERY PERFORMED DUE TO PATIENT CONDITION FOR DISLOCATION OF CUSTOM-MADE DEVISE IMPLANTED ON JANUARY 24TH. CORRECTIVE CUSTOM-MADE IMPLANT WAS IMPLANTED. (PATIENT CONDITION).

    Description of Event or Problem · 0

    SMR REVERSE REVISION SURGERY PLANNED BUT NOT YET PERFORMED DUE TO DISLOCATION AND PAIN. ACCORDING TO THE COMPLAINT SOURCE, PATIENT HAS A VERY COMPLICATED CLINICAL HISTORY: ON (B)(6) 2022 PATIENT PRESENTED WITH DISLOCATION AND OPEN REDUCTION WAS PLANNED; ON (B)(6) 2022 THE OPEN REDUCTION WITH FRACTURE REPAIR WAS COMPLETED SUCCESSFULLY. THIS EVENT WAS REGISTERED AS LIMA CORPORATE COMPLAINT (B)(4) AND REPORTED TO FDA AS MFR 3008021110-2022-00111. ON (B)(6) 2022 PATIENT PRESENTED WITH PAIN AFTER POST OPERATIVE EXERCISES. X-RAYS SHOWED DISLOCATION AND SIGNS OF IMPLANT LOOSENING; REVISION SURGERY PERFORMED ON (B)(6) 2022. DURING THE REVISION SURGEON, SURGEON COMMENTED HE OPTED FOR A STANDARD GLENOSPHERE TO BE IMPLANTED BUT THE IDEAL COMPONENT TO BE IMPLANTED WOULD HAVE BEEN A COMPASSIONATE USE DEVICE COMPONENT (HP REVERSE GLENOSPHERE). THIS EVENT IS REGISTERED AS LIMA CORPORATE COMPLAINT (B)(4) AND WAS REPORTED TO FDA AS MFR 3008021110-2022-00110. SMR REVERSE REVISION SURGERY PLANNED BUT NOT YET PERFORMED DUE TO DISLOCATION AND PAIN (OBJECT OF THIS REPORT). EVENT HAPPENED IN US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2210839 SMR REVERSE LINER RETENTIVE SMR REVERSE LINER RETENTIVE PHX LIMACORPORATE S.P.A 1365.50.816 19AT0WE
    506117 SMR REVERSE LINER RETENTIVE SMR REVERSE LINER RETENTIVE PHX LIMACORPORATE S.P.A 1365.50.816 19AT0WE

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention