BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMR SHOULDER

    MDR report key: 22368592 · Received July 1, 2025

    Report

    Report Number
    3008021110-2025-00084
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    May 15, 2025
    Report Date
    June 30, 2025
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    HSD
    UDI-DI
    08033390000888
    PMA / PMN Number
    K101263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2431073, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 30 DEVICES MANUFACTURED WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. WE SUBMIT A FINAL MDR WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2431073, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 20 DEVICES MANUFACTURED WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. DEVICE ANALYSIS THE SUSPECTED DEVICE WAS RETURNED TO LIMACORPORATE S.P.A. FOR FURTHER INVESTIGATION. THE DEVICE UNDERWENT A DIMENSIONAL ANALYSIS TO VERIFY COMPLIANCE WITH THE APPLICABLE TECHNICAL DRAWINGS AND SPECIFICATIONS. THE RESULTS OF THIS ANALYSIS CONFIRMED THAT ALL MEASURED DIMENSIONS WERE WITHIN TOLERANCE AND FULLY COMPLIANT WITH THE DESIGN SPECIFICATIONS. THEREFORE, A DIMENSIONAL NONCONFORMITY OF THE DEFINITIVE STEM WAS EXCLUDED. BASED ON THESE FINDINGS, THE ISSUE OBSERVED INTRAOPERATIVELY DOES NOT APPEAR TO BE ATTRIBUTABLE TO A DEFECT OF THE DEFINITIVE STEM ITSELF. TWO ALTERNATIVE EXPLANATIONS WERE THEREFORE CONSIDERED: 1. THE TRIAL STEM USED DURING SURGERY MAY NOT HAVE BEEN 14 MM SIZE, BUT RATHER A LARGER SIZE (E.G. 16 MM). THIS HYPOTHESIS CANNOT BE VERIFIED RETROSPECTIVELY, AS THE INFORMATION IS NO LONGER AVAILABLE FOR ANALYSIS. 2. DURING IMPLANTATION OF THE 14 MM DEFINITIVE STEM, THE PRESENCE OF CANCELLOUS BONE TISSUE MAY HAVE INTERFERED WITH PROPER SEATING AND PRIMARY FIXATION OF THE STEM WITHIN THE HUMERAL CANAL. THIS LATTER HYPOTHESIS IS SUPPORTED BY THE POSTOPERATIVE RADIOGRAPHIC ASSESSMENT, WHICH SHOWED THAT THE 16 MM DEFINITIVE STEM WAS CORRECTLY IMPLANTED AND ACHIEVED ADEQUATE CORTICAL CONTACT WITHIN THE HUMERAL CANAL. THE EXACT ROOT CAUSE OF THE EVENT CANNOT BE CONCLUSIVELY DETERMINED DUE TO THE LIMITED INFORMATION AVAILABLE AND THE IMPOSSIBILITY OF VERIFYING THE SIZE OF THE TRIAL COMPONENT USED INTRAOPERATIVELY. HOWEVER, CONSIDERING THAT: THE REVIEW OF DEVICE HISTORY RECORDS FOR THE INVOLVED LOT DID NOT IDENTIFY ANY MANUFACTURING ANOMALIES OR NONCONFORMITIES. DIMENSIONAL ANALYSIS CONFIRMED THAT THE RETURNED DEFINITIVE STEM WAS FULLY COMPLIANT WITH THE DESIGN SPECIFICATIONS. ADEQUATE FIXATION WAS ACHIEVED WITH A LARGER STEM SIZE (16 MM), AS CONFIRMED BY POSTOPERATIVE RADIOGRAPHS. IT CAN BE CONCLUDED, BASED ON THE AVAILABLE EVIDENCE, THAT THE REPORTED EVENT IS NOT PRODUCT-RELATED. THE EVENT IS MORE LIKELY ATTRIBUTABLE TO INTRAOPERATIVE FACTORS, SUCH AS TRIAL SELECTION OR BONE-RELATED CONDITIONS AFFECTING PRIMARY FIXATION. POST MARKET SURVEILLANCE DATA ACCORDING TO THE AVAILABLE PMS DATA, THE OCCURRENCE RATE OF SMR CEMENTLESS FINNED STEM L. 80 MM BELONGING TO THE FAMILY PRODUCT CODE 1304.15.1XX - 240 RELATED TO CASES IN WHICH THE DEFINITIVE IMPLANT FITS DIFFERENTLY COMPARED TO THE TRIAL COMPONENT, IS LOWER THAN 0.001%. 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. PLEASE NOTE: THIS IS A FINAL MDR REPORT.

    Description of Event or Problem · 0

    DURING RSA ON (B)(6) 2025, TRIAL STEM (14MM) WAS FIRMLY FIXED. HOWEVER, DEFINITIVE STEM (14MM) WAS LOOSE AND SPUN AROUND ON THE PATIENT. THE SURGEON PERFORMED TRIALING AGAIN, AND DEFINITIVE STEM (16MM) WAS IMPLANTED. DUE TO THE EVENT, SURGICAL TIME WAS EXTENDED FOR ABOUT 20 MINUTES. BELOW IS THE SUSPECTED PRODUCT: · SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.140, LOT #2431073 - STER. #2500015) - PRODUCT SOLD IN US. THE PATIENT IS A 75 -YEAR-OLD MALE. EVENT HAPPENED IN JAPAN.

    Description of Event or Problem · 0

    DURING RSA ON (B)(6) 2025, TRIAL STEM (14MM) WAS FIRMLY FIXED. HOWEVER, DEFINITIVE STEM (14MM) WAS LOOSE AND SPUN AROUND ON THE PATIENT. THE SURGEON PERFORMED TRIALING AGAIN, AND DEFINITIVE STEM (16MM) WAS IMPLANTED. DUE TO THE EVENT, SURGICAL TIME WAS EXTENDED FOR ABOUT 20 MINUTES. BELOW IS THE SUSPECTED PRODUCT: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.140, LOT #2431073 - STER. #(B)(4) - PRODUCT SOLD IN US THE PATIENT IS A 75 -YEAR-OLD MALE. EVENT HAPPENED IN JAPAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261569 SMR SHOULDER FINNED STEM HSD LIMACORPORATE S.P.A 1304.15.140 2431073 08033390000888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other