BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SYSTEM

    MDR report key: 18435258 · Received January 3, 2024

    Report

    Report Number
    3008021110-2023-00144
    Event Type
    Injury
    Date Received
    January 3, 2024
    Date of Event
    September 22, 2021
    Report Date
    March 26, 2025
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    KWS
    UDI-DI
    08033390272339
    PMA / PMN Number
    K163397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF INVOLVED LOT NUMBERS, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE COMPONENTS MANUFACTURED WITH THAT LOT NUMBER. THIS IS THE FIRST AND ONLY COMPLAINT REPORTED ON THE INVOLVED LOT NUMBERS. A FINAL REPORT WILL BE SENT AFTER THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    BY CHECKING THE DHRS OF LOT. 2017864 - STER. (B)(4) AND LOT. 17AT0U9 - STER (B)(4), NO PRE-EXISTING ANOMALY WAS DETECTED ON THE DEVICES MANUFACTURED WITH THESE LOT NUMBERS INVOLVED. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) SMR ECCENT. GLENOSPHERE Ø 36MM WITH LOT. 2017864 - STER. (B)(4) HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE INVOLVED LOT NUMBER. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) SMR REVERSE LINER + 6 MM PIECES MANUFACTURED WITH LOT. 17AT0U9 - STER. (B)(4) HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE INVOLVED LOT NUMBER. THE EXPLANTS WERE NOT RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. LIMACORPORATE RECEIVED PRE- AND POST-OPERATIVE X-RAYS OF REVISION SURGERY. THE AVAILABLE INFORMATION AND X-RAYS HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "APPARENTLY THERE IS A CUSTOM-MADE GLENOID COMPONENT IN PLACE, THAT IS NOT ROUTINELY USED BUT DEDICATED TO SEVERE GLENOID EROSION AND BONE LOSS, WHICH CAN OCCUR AFTER MULTIPLE REVISIONS, INFECTION ETC., BUT WE DO NOT HAVE INFORMATION ABOUT THIS. INSTABILITY AFTER RTSA IS A COMMON COMPLICATION AND REASON FOR REVISION, ESPECIALLY IN THE ELDERLY. THIS HAPPENED HERE, I THINK IT IS A FATEFUL COURSE OF EVENTS." 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, INSTABILITY AFTER RTSA, A COMMON COMPLICATION IN THE ELDERLY, OCCURRED AS A FATEFUL COURSE OF EVENTS, WITH NO SIGNS OF IMPLANT-RELATED FAILURE. 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.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2021 DUE TO RIGHT REVERSE SHOULDER DISLOCATION. PATIENT: FEMALE, 75 YEARS OLD. DURING THE REVISION SURGERY, THE FOLLOWING DEVICES WERE REMOVED: SMR ECCENT. GLENOSPHERE Ø 36MM (PRODUCT CODE: 1376.09.031 LOT NR. 2017864 - STER. NR. 2000317); SMR REVERSE LINER + 6 MM (PRODUCT CODE: 1360.50.020 LOT. NR. 17AT0U9 - STER. NR. 1700198) - NOT SOLD IN US; SMR CEMENTED STEM Ø12 MM (PRODUCT CODE: 1306.15.120 LOT. NR. 1813538); SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE: 1352.15.005 LOT. NR: 2021424 - STER. NR. 2000404); SMR CONNECTOR SMALL STD (PRODUCT CODE: 1374.15.310 LOT. NR. 2111864 - STER. NR. 2100184) . EVENT OCCURRED IN UNITED KINGDOM. PREVIOUS SURGERY PERFORMED ON (B)(6) 2021.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2021 DUE TO RIGHT REVERSE SHOULDER DISLOCATION. BEFORE THE PROCEDURE THE PATIENT FELT PAIN AND CLUNKING SENSATION. PATIENT: FEMALE, 75 YEARS OLD, HEIGHT 1,46 M AND WEIGHT AT THE TIME OF PREVIOUS SURGERY 100,80 KG. DURING THE REVISION SURGERY, THE FOLLOWING DEVICES WERE REMOVED: SMR ECCENT. GLENOSPHERE Ø 36MM (PRODUCT CODE: 1376.09.031 LOT NR. 2017864 - STER. NR. (B)(4)). SMR REVERSE LINER + 6 MM (PRODUCT CODE: 1360.50.020 LOT. NR. 17AT0U9 - STER. NR. (B)(4)). SMR CEMENTED STEM Ø12 MM (PRODUCT CODE: 1306.15.120 LOT. NR. (B)(4)). SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE: 1352.15.005 LOT. NR: 2021424 - STER. NR. (B)(4)). SMR CONNECTOR SMALL STD (PRODUCT CODE: 1374.15.310 LOT. NR. 2111864 - STER. NR. (B)(4)). EVENT OCCURRED IN UNITED KINGDOM. PREVIOUS SURGERY PERFORMED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435158 SMR SYSTEM SMR SYSTEM - GLENOSPHERE ECCENTRICAL DIA. 36 MM KWS LIMACORPORATE S.P.A 1376.09.031 2017864 08033390272339

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention