BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE FINNED HUMER. BODY

    MDR report key: 15266997 · Received August 22, 2022

    Report

    Report Number
    3008021110-2022-00075
    Event Type
    Injury
    Date Received
    August 22, 2022
    Date of Event
    August 8, 2022
    Report Date
    November 21, 2022
    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

    THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE LOT NUMBERS INVOLVED. NO PRE-EXISTING ANOMALY WAS FOUND CHECKING THE STERILIZATION CHARTS OF THE COMPONENTS OF THE SAME LOTS. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE LOT NUMBERS INVOLVED. NO PRE-EXISTING ANOMALY WAS FOUND CHECKING THE STERILIZATION CHARTS OF THE COMPONENTS OF THE SAME LOTS. EXPLANTS ANALYSIS AND FURTHER INFORMATION THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. FURTHER INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, IN PARTICULAR: - THE DATE OF THE PRE-OPERATIVE X-RAY SHARED - THE CO-MORBIDITIES AND THE AGE OF THE PATIENT - THE PATHOGEN INVOLVED IN THE INFECTION NO OTHER INFORMATION WAS AVAILABLE. X-RAYS ANALYSIS THE X-RAYS PROVIDED (THE DATE IS UNKNOWN) WERE SENT TO THE MEDICAL EXPERT, WHO STATED THAT "THE RADIOGRAPHS SHOW CLEAR AND TYPICAL EVIDENCE OF INFECTION: OSTEOLYTIC BONE RESORPTION BOTH AT THE GLENOID AND THE PROXIMAL HUMERUS. THE COMPONENTS ITSELF LOOK UNREMARKABLE. IN SUMMARY INFECTION IS THE CAUSE OF REVISION, NO SIGNS OF IMPLANT-RELATED PROBLEMS". IN CONCLUSION: - THE CHECK OF THE STERILIZATION CHARTS HIGHLIGHTS NO PRE-EXISTING ANOMALY ON THE ITEMS BELONGING TO THE INVOLVED LOT NUMBERS. - NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT, EXCEPT FOR THE GENDER, THE BMI AND THE ACTIVITY LEVEL OF THE PATIENT. - ACCORDING TO THE OPINION OF THE MEDICAL EXPERT, THE RADIOGRAPHS SHOW OSTEOLYTIC BONE RESORPTION BOTH AT THE GLENOID AND THE PROXIMAL HUMERUS, THAT IS TYPICAL EVIDENCE OF INFECTION, AND THERE ARE NO SIGNS OF IMPLANT-RELATED PROBLEMS. WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, WE ESTIMATE A REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO INFECTION TO BE 0,079%. NO SPECIFIC CORRECTIVE ACTION IS NEEDED FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO INFECTION. DURING THE SURGERY THE FOLLOWING COMPONENTS WERE REMOVED: SMR REVERSE FINNED HUMER. BODY (PRODUCT CODE 1352.15.050, LOT NUMBER 2202600, STERILIZATION NUMBER 2200061) SMR REV. HP LAT. LINER MEDIUM (PRODUCT CODE 1365.09.115, LOT NUMBER 2126887, STERILIZATION NUMBER 2200044) SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT NUMBER 2123948, STERILIZATION NUMBER 2100338) SMR REVERSE HP GLENOSPH. 40 MM (PRODUCT CODE 1374.50.400, LOT NUMBER 2200765, STERILIZATION NUMBER 2200031) ALL THE ABOVE-MENTIONED COMPONENTS WERE REMOVED AS PER SURGICAL TECHNIQUE. AFTER WASHING OUT, NEW COMPONENTS WERE IMPLANTED AS PER SURGICAL TECHNIQUE. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. OTHER DETAILS ABOUT THE CLINICAL CONDITION OF THE PATIENT ARE NOT AVAILABLE. THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO INFECTION, THE PATHOGEN RESPONSIBLE IS UNKNOWN. DURING THE SURGERY THE FOLLOWING COMPONENTS WERE REMOVED: - SMR REVERSE FINNED HUMER. BODY (PRODUCT CODE 1352.15.050, LOT NUMBER 2202600, STERILIZATION NUMBER 2200061) - SMR REV. HP LAT. LINER MEDIUM (PRODUCT CODE 1365.09.115, LOT NUMBER 2126887, STERILIZATION NUMBER 2200044). - SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT NUMBER 2123948, STERILIZATION NUMBER 2100338). - SMR REVERSE HP GLENOSPH. 40 MM (PRODUCT CODE 1374.50.400, LOT NUMBER 2200765, STERILIZATION NUMBER 2200031). ALL THE ABOVE-MENTIONED COMPONENTS WERE REMOVED AS PER SURGICAL TECHNIQUE. AFTER WASHING OUT, NEW COMPONENTS WERE IMPLANTED AS PER SURGICAL TECHNIQUE. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT WAS A FEMALE, AGE UNKNOWN, WITH MODERATE BMI AND LOW ACTIVITY LEVEL. OTHER DETAILS ABOUT THE CLINICAL CONDITION OF THE PATIENT ARE NOT AVAILABLE. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451683 SMR REVERSE FINNED HUMER. BODY FINNED REVERSE HUMERAL BODY FOR TRAUMA, KWS LIMACORPORATE S.P.A. 1352.15.050 2202600

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention