BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY

    MDR report key: 15823012 · Received November 18, 2022

    Report

    Report Number
    3008021110-2022-00116
    Event Type
    Injury
    Date Received
    November 18, 2022
    Date of Event
    April 13, 2021
    Report Date
    February 19, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING CHARTS WERE CHECKED WITH THE FOLLOWING RESULTS: NO PRE-EXISTING ANOMALY WAS FOUND ON THE (B)(4), BELONGING TO PRODUCT CODE: 1352.15.010, LOT NUMBER: 1703055, STERILIZATION NUMBER: 1700136; NO PRE-EXISTING ANOMALY WAS FOUND ON THE (B)(4), BELONGING TO PRODUCT CODE: 1360.50.810, LOT NUMBER: 16AT14N, STERILIZATION NUMBER: 1700036; NO PRE-EXISTING ANOMALY WAS FOUND ON THE (B)(4), BELONGING TO PRODUCT CODE: 1374.09.105, LOT NUMBER: 1814560, STERILIZATION NUMBER: 1800315; NO PRE-EXISTING ANOMALY WAS FOUND ON THE (B)(4), BELONGING TO PRODUCT CODE: 1375.14.652, LOT NUMBER: 1804710, STERILIZATION NUMBER: 1800179; NO PRE-EXISTING ANOMALY WAS FOUND ON THE (B)(4), BELONGING TO PRODUCT CODE: 1375.15.605, LOT NUMBER: 1814813, STERILIZATION NUMBER: 1800317. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION THE MANUFACTURING CHARTS WERE CHECKED WITH THE FOLLOWING RESULTS: - NO PRE-EXISTING ANOMALY WAS FOUND ON THE 63 ITEMS, BELONGING TO PRODUCT CODE 1352.15.010, LOT NUMBER 1703055, STERILIZATION NUMBER (B)(6). - NO PRE-EXISTING ANOMALY WAS FOUND ON THE 60 ITEMS, BELONGING TO PRODUCT CODE 1360.50.810, LOT NUMBER 16AT14N, STERILIZATION NUMBER (B)(6). - NO PRE-EXISTING ANOMALY WAS FOUND ON THE 72 ITEMS, BELONGING TO PRODUCT CODE 1374.09.105, LOT NUMBER 1814560, STERILIZATION NUMBER (B)(6). - NO PRE-EXISTING ANOMALY WAS FOUND ON THE 63 ITEMS, BELONGING TO PRODUCT CODE 1375.14.652, LOT NUMBER 1804710, STERILIZATION NUMBER (B)(6). - NO PRE-EXISTING ANOMALY WAS FOUND ON THE 42 ITEMS, BELONGING TO PRODUCT CODE 1375.15.605, LOT NUMBER 1814813, STERILIZATION NUMBER (B)(6). NO X-RAYS NOR EXPLANTS WERE AVAILABLE TO BE RETURNED. HOWEVER, THE WHOLE PATIENT'S HISTORY HAS BEEN SHARED WITH THE MEDICAL EXPERT, ASKING FOR HIS EVALUATION. BASED ON HIS ASSESSMENT: "IN RETROSPECT, ALL SURGERIES SEEM TO BE CARRIED OUT IN A REASONABLE WAY WITH GOOD INTENTIONS AND INDICATIONS. THE FIRST IMPLANTATION FAILED BECAUSE OF TRAUMA, NO FURTHER INFORMATION ABOUT FRACTURE PATTERN AVAILABLE. TO STEP BACK TO CTA SITUATION AND GLENOID BONE GRAFTING IS A COMMON OPTION. TO CONVERT THE HEMI TO RTSA IN A SECOND STAGE IS ALSO A REASONABLE INDICATION, BECAUSE OF LESS EXPECTED PAIN WITH RTSA AND BETTER FUNCTION COMPARED TO HEMI. THE REVISION FOR INFECTION IS A FATEFUL COURSE OF EVENT, A NEGATIVE RISK THAT DID GET REALIZED. THERE IS NO SIGN OF IMPLANT-RELATED FAILURE." THEREFORE, CONSIDERING THAT: - CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS INVOLVED IN THE COMPLAINT, NO PRE-EXISTING ANOMALY WAS FOUND - ACCORDING TO THE INFORMATION RECEIVED BY THE MEDICAL EXPERT, THERE IS NO SIGN OF IMPLANT-RELATED FAILURE WE CAN CONCLUDE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO THE RELEVANT PMS DATA, THE REVISION RATE OF THE SMR REVERSE HUMERAL BODY BELONGING TO THE FAMILY CODE 1352.15.XXX AND 1352.20.XXX DUE TO TRAUMA IS AROUND 0.03%. NO CORRECTIVE ACTION IS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER CASE. THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2021, POTENTIALLY DUE TO CAR ACCIDENT POST-SURGERY. DURING THE REVISION SURGERY, THE PATIENT WAS REVISED TO AN ANATOMIC CONFIGURATION WITH A BONE GRAFT AND UNKNOWN GLENOID SIDE AND HEMI LIMA HUMERAL SIDE. DURING THE REVISION SURGERY THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR REVERSE HUMERAL BODY (PRODUCT CODE: 1352.15.010, LOT NUMBER: 1703055, STERILIZATION NUMBER: 1700136); SMR REVERSE LINER STANDARD (PRODUCT CODE: 1360.50.810, LOT NUMBER: 16AT14N, STERILIZATION NUMBER: 1700036); SMR GLENOSPHERE Ø36MM SMALL-R (PRODUCT CODE: 1374.09.105, LOT NUMBER: 1814560, STERILIZATION NUMBER: 1800315); SMR GLENOID PEG TT SMALL-R #M (PRODUCT CODE: 1375.14.652, LOT NUMBER: 1804710, STERILIZATION NUMBER: 1800179); SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE: 1375.15.605, LOT NUMBER: 1814813, STERILIZATION NUMBER: 1800317). THE PATIENT WAS A FEMALE, 65 YEARS OLD. PATIENT'S CLINICAL HISTORY: PRIMARY SURGERY TOOK PLACE IN 2018, AFTER DISLOCATION/SEPARATION, WITHOUT ANY IMPLANT. THE TOTAL SHOULDER ARTHROPLASTY, USING LIMA IMPLANTS, TOOK PLACE ON (B)(6) 2019. AT THE END OF RECOVERY, THE PATIENT GOT T-BONED IN A CAR ACCIDENT THAT CAUSED FRACTURES OF THE RIGHT SHOULDER AS WELL AS A FROZEN SHOULDER. THE PATIENT WAS FOLLOWED FOR ONE YEAR FOLLOWING ACCIDENT. THE FIRST REVISION SURGERY TOOK PLACE ON (B)(6) 2021, PROBABLY DUE TO CAR ACCIDENT, HEREBY REPORTED. THE SECOND REVISION SURGERY TOOK PLACE ON (B)(6) 2021. THIS REVISION WAS REGISTERED WITH THE INTERNAL COMPLAINT (B)(6) AND REPORTED WITH THE MFR 3008021110-2022-000119. THE THIRD REVISION SURGERY TOOK PLACE ON (B)(6) 2022, DUE TO INFECTION. THIS REVISION WAS REGISTERED WITH THE INTERNAL COMPLAINT (B)(6) AND REPORTED WITH THE MFR 3008021110-2022-00120 EVENT HAPPENED IN UNITED STATES.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON APRIL 13TH, 2021, POTENTIALLY DUE TO CAR ACCIDENT POST-SURGERY. DURING THE REVISION SURGERY, THE PATIENT WAS REVISED TO AN ANATOMIC CONFIGURATION WITH A BONE GRAFT AND UNKNOWN GLENOID SIDE AND HEMI LIMA HUMERAL SIDE. DURING THE REVISION SURGERY THE FOLLOWING COMPONENTS WERE EXPLANTED: - SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.15.010, LOT NUMBER 1703055, STERILIZATION NUMBER (B)(6)). - SMR REVERSE LINER STANDARD (PRODUCT CODE 1360.50.810, LOT NUMBER 16AT14N, STERILIZATION NUMBER (B)(6)). - SMR GLENOSPHERE Ø36MM SMALL-R (PRODUCT CODE 1374.09.105, LOT NUMBER 1814560, STERILIZATION NUMBER (B)(6)). - SMR GLENOID PEG TT SMALL-R #M (PRODUCT CODE 1375.14.652, LOT NUMBER 1804710, STERILIZATION NUMBER (B)(6)) - SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT NUMBER 1814813, STERILIZATION NUMBER (B)(6)). THE PATIENT WAS A FEMALE, 65 YEARS OLD. PATIENT'S CLINICAL HISTORY: - PRIMARY SURGERY TOOK PLACE IN 2018, AFTER DISLOCATION/SEPARATION, WITHOUT ANY IMPLANT. - THE TOTAL SHOULDER ARTHROPLASTY, USING LIMA IMPLANTS, TOOK PLACE ON (B)(6) 2019. AT THE END OF RECOVERY, THE PATIENT GOT T-BONED IN A CAR ACCIDENT THAT CAUSED FRACTURES OF THE RIGHT SHOULDER AS WELL AS A FROZEN SHOULDER. THE PATIENT WAS FOLLOWED FOR ONE YEAR FOLLOWING ACCIDENT. - THE FIRST REVISION SURGERY TOOK PLACE ON (B)(6) 2021, PROBABLY DUE TO CAR ACCIDENT, HEREBY REPORTED. - THE SECOND REVISION SURGERY TOOK PLACE ON (B)(6) 2021. THIS REVISION WAS REGISTERED WITH THE INTERNAL COMPLAINT 298/22 AND REPORTED WITH THE MFR 3008021110-2022-000119. - THE THIRD REVISION SURGERY TOOK PLACE ON (B)(6) 2022, DUE TO INFECTION. THIS REVISION WAS REGISTERED WITH THE INTERNAL COMPLAINT 300/22 AND REPORTED WITH THE MFR 3008021110-2022-00120. EVENT HAPPENED IN UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322565 SMR REVERSE HUMERAL BODY SMR SHOULDER SYSTEM - REVERSE HUMERAL BODY FOR ELECTIVE SURGERY KWS LIMACORPORATE S.P.A. 1352.15.010 1703055

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention