BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOSPHERE DIA. 36MM

    MDR report key: 18911960 · Received March 15, 2024

    Report

    Report Number
    3008021110-2024-00027
    Event Type
    Injury
    Date Received
    March 15, 2024
    Date of Event
    March 11, 2024
    Report Date
    May 31, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBF
    PMA / PMN Number
    K163397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING CHARTS AND STERILIZATION OF THE T LOT #S INVOLVED WERE CHECKED AND NO PRE-EXISTING ANOMALY WAS FOUND. THIS IS THE FIRST AND ONLY COMPLAINT RELATED TO THE LOT# INVOLVED. WE WILL SUBMIT A FOLLOW UP REPORT WHEN INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION. THE MANUFACTURING AND STERILIZATION CHARTS OF THE LOTS INVOLVED WERE CHECKED AND NO PRE-EXISTING ANOMALY WAS FOUND. THIS IS THE FIRST AND ONLY COMPLAINT RELATED TO THE LOTS INVOLVED. THE EXPLANTED ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. THE COMPLAINT SOURCE SHARED THE X-RAYS, PROBABLY TAKEN IN JANUARY 2024. ACCORDING TO THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, THE EXACT DATE OF THE X-RAYS IN UNKNOWN, BUT THEY SEEM TO COINCIDE WITH THE PATIENT'S CLINICAL EVALUATION DONE IN THE SAME MONTH. THE X-RAYS WERE SHARED WITH THE MEDICAL EXPERT, WHO STATED THAT "THE RADIOGRAPHS LOOK UNREMARKABLE. THERE IS NO SIGN FOR IMPLANT RELATED ISSUES OR SURGICAL ERRORS. IT TURNS OUT, THAT INFECTION IS THE MOST LIKELY REASON FOR REVISION. THIS IS AN UNFORTUNATE COURSE OF EVENTS." THEREFORE, CONSIDERING THAT: - THE MANUFACTURING AND STERILIZATION CHARTS OF THE LOTS INVOLVED WERE CHECKED AND NO PRE-EXISTING ANOMALY WAS FOUND. - ACCORDING TO THE MEDICAL EXPERT'S OPINION, THERE IS NO SIGN FOR IMPLANT RELATED ISSUES OR SURGICAL ERRORS, BY LOOKING AT THE X-RAYS. WE CAN CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA ACCORDING TO THE RELEVANT PMS DATA, THE OCCURRENCE RATE OF REVISION SURGERIES DUE TO INFECTION THAT INVOLVED SMR GLENOSPHERE BELONGING TO THE FAMILY CODES 1374.09.XXX, 1376.09.XXX, 1374.15.XXX IS AROUND 0,15% BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTION IS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    PATIENT REPORTED THAT HE HAD FALLEN AND HAS PAIN / DISLOCATION THAT IS WORSENING, AND SURGERY IS TBD. UPDATE - 12/3/2024 - SURGEON REPORTED HAD PLANNED TO OPERATE WITH STANDARD COMPONENTS INSTEAD OF THE REVERSE HP BUT THE PATIENT WAS INFECTED, SO HE REMOVED ALL COMPONENTS. PATIENT INFORMATION MALE DATE OF BIRTH - (B)(6) 1953 EVENT HAPPENED IN THE U.S. COMPONENTS EXPLANTED; SMR FINNED STEM SHORT D.18, COMMERCIAL CODE 1304.15.018 - LOT #2201640 STER. #2200083 SMR HUMERAL EXTENSION + 9 MM, COMMERCIAL CODE 1352.15.001 - LOT #2122039 - STER. #2100350 SMR REVERSE FINNED HUMER. BODY, COMMERCIAL CODE 1352.15.050 - LOT #2220096 - STER. #2200261 SMR REVERSE LINER STANDARD, COMMERCIAL CODE 1360.50.810 - LOT #21AT33S - STER. #2200090 SMR GLENOSPHERE Ø 36MM, COMMERCIAL CODE 1374.09.111 - LOT #2122544 - STER. #2100330 SMR CONNECTOR SMALL STD, COMMERCIAL CODE 1374.15.310 - LOT #2124379 -STER.#2200020 SMR GLENOID PEG TT S/STD #M, COMMERCIAL CODE 1375.14.662 - LOT #2118351 - STER. #2200076 SMR GLENOID BASEPLATE SMALL 1375.15.620 - LOT #1511376 - STER. #2100049

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2024, AFTER THE PATIENT HAD FALLEN. THE PATIENT UNDERWENT A RIGHT REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2023, AND DURING THE FOLLOW UP PERFORMED ON (B)(6) 2024, THE SURGEON NOTICED THE INSTABILITY OF THE RIGHT SHOULDER REVERSE ARTHROPLASTY AND PLANNED A REVISION. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2024, BUT DURING THE SURGERY, SEROPURULENT FLUID WAS FOUND IN THE JOINT. THIS WAS CULTURED AND THE DECISION WAS MADE TO PLACE A HEMI SPACER FOR INFECTION. THE FOLLOWING COMPONENTS WERE REMOVED: · SMR FINNED STEM SHORT D.18, COMMERCIAL CODE 1304.15.018 - LOT 2201640, STERILIZATION 2200083. · SMR HUMERAL EXTENSION + 9 MM, COMMERCIAL CODE 1352.15.001 - LOT 2122039, STERILIZATION 2100350 · SMR REVERSE FINNED HUMER. BODY, COMMERCIAL CODE 1352.15.050 - LOT 2220096, STERILIZATION 2200261 · SMR REVERSE LINER STANDARD, COMMERCIAL CODE 1360.50.810 - LOT 21AT33S, STERILIZATION 200090. · SMR GLENOSPHERE Ø 36MM, COMMERCIAL CODE 1374.09.111 - LOT 2122544, STERILIZATION 2100330. · SMR CONNECTOR SMALL STD, COMMERCIAL CODE 1374.15.310 - LOT 2124379, STERILIZATION 2200020. · SMR GLENOID PEG TT S/STD #M, COMMERCIAL CODE 1375.14.662 - LOT 2118351, STERILIZATION 2200076. · SMR GLENOID BASEPLATE SMALL 1375.15.620 - LOT 1511376, STERILIZATION 2100049. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1953. EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472152 GLENOSPHERE DIA. 36MM GLENOSPHERE DIA. 36MM MBF LIMACORPORATE S.P.A. 1374.09.111 2122544

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention