BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMIC SHOULDER PROSTHESIS

    MDR report key: 22585412 · Received July 24, 2025

    Report

    Report Number
    3005180920-2025-00663
    Event Type
    Injury
    Date Received
    July 24, 2025
    Date of Event
    July 7, 2025
    Report Date
    September 12, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040713122
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 JULY 2025. LOT: 2344616: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23/02/2024. EXPIRATION DATE: 11/02/2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION: REVISION TWO WEEKS AFTER THE PREVIOUS REVISION SURGERY BECAUSE DETACHMENT OF THE HUMERAL HEAD FROM THE DOUBLE ECCENTRIC WAS FOUND. THIS COULD BE DUE TO THE FACT THAT THE BONE ON THE HUMERAL TUBEROSITY PREVENTED THE HEAD FROM REACHING ITS FINAL POSITION. THE SURGEON REVISED THE HUMERAL HEAD AND DOUBLE ECCENTRIC AND TRIMMED THE SURROUNDING BONE USING A RONGEUR. R&D INVESTIGATION: THE HUMEAL HEAD WAS REPORTED TO HAVE DISENGAGED FROM THE DOUBLE ECCENTER 10 DAYS AFTER A CONVERSION FROM A REVERSE TO A HEMI IMPLANT. THE DISSOCIATION BETWEEN THE TWO COMPONENTS MAY BE ASSOCIATED WITH A POTENTIAL CONFLICT BETWEEN THE HEAD AND THE SURROUNDING BONE (WHICH WAS THEN REMOVED IN THE REVISION CASE) DURING THE HEAD IMPACTION. IT IS NOT POSSIBLE TO EXCLUDE THE PRESENCE OF SOFT TISSUES WITHIN THE MORSE-TAPER THAT MAY HAVE CONTRIBUTED TO AN INCORRECT ENGAGEMENT OF THE TAPER. NO ACTION IS SUGGESTED. OTHER DEVICES INVOLVED: ANATOMICAL SHOULDER SYSTEM 04.01.0097 METAL HUMERAL HEAD Ø54 (K170910) LOT: 2114060: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02/05/2022. EXPIRATION DATE: 13/04/2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THE EVENT MAY BE ATTRIBUTED TO PATIENT-SPECIFIC ANATOMICAL OR PHYSIOLOGICAL CONDITIONS (E.G., INTERFERENCE FROM ADJACENT BONE STRUCTURES OR POTENTIAL SOFT TISSUE INTERPOSITION WITHIN THE TAPER) THAT INTERFERED WITH THE PROPER SEATING OF THE COMPONENTS DURING IMPLANTATION. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 0

    R&D INVESTIGATION: THE HUMERAL HEAD WAS REPORTED TO HAVE DISENGAGED FROM THE DOUBLE ECCENTER 10 DAYS AFTER A CONVERSION FROM A REVERSE TO A HEMI IMPLANT. THE HUMERAL HEAD Ø54 LOT. 2114060 DOESN'T SHOW ANY MAJOR SIGN OF WEAR OR USAGE. THE MORSE TAPER INTERFACE ONLY DISPLAYS A LIGHT SHADE WHERE IT ENGAGES THE DOUBLE ECCENTER MORSE TAPER CONNECTOR. THE DOUBLE ECCENTER (REF. (B)(4)) LOT 2344616 DOES NOT DISPLAY ANY MAJOR SIGNS OF WEAR OR ANY SIGNS OF MISCOUPLING. THE DOUBLE ECCENTER SCREW DOES NOT DISPLAY ANY SIGN OF WEAR, THE THREAD IS INTACT IN ALL ITS LENGTH AND NO CONTACT MARKINGS ARE PRESENT IN ITS CYLINDRICAL PORTION. THE DISSOCIATION BETWEEN THE TWO COMPONENTS MAY BE ASSOCIATED WITH A POTENTIAL CONFLICT BETWEEN THE HEAD AND THE SURROUNDING BONE (WHICH WAS THEN REMOVED IN THE REVISION CASE) DURING THE HEAD IMPACTION. IT IS NOT POSSIBLE TO EXCLUDE THE PRESENCE OF SOFT TISSUES WITHIN THE MORSE-TAPER THAT MAY HAVE CONTRIBUTED TO AN INCORRECT ENGAGEMENT OF THE TAPER. NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. THE CONCLUSION REMAINED UNCHANGED.

    Description of Event or Problem · 0

    ABOUT TWO WEEKS AFTER THE PREVIOUS REVISION SURGERY, THE HUMERAL HEAD WAS FOUND DETACHED FROM THE DOUBLE ECCENTRIC. THE SURGEON REVISED THE HUMERAL HEAD AND THE DOUBLE ECCENTRIC AND TRIMMED THE SURROUNDING BONE BY USING A RONGEUR. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT HISTORY: PRIMARY SURGERY PERFORMED ON (B)(6) 2025. FIRST REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. SECOND REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. THIRD REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER, GLENOSPHERE, AND METAPHYSIS REVISED. FOURTH REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE JOINT LUXATION; PATIENT CONVERTED TO HEMIARTHROPLASTY - GLENOSPHERE AND BASEPLATE REMOVED, LINER AND METAPHYSIS REPLACED WITH ANATOMICAL COMPONENTS. THIS IS THE FIFTH REVISION SURGERY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1774406 ANATOMIC SHOULDER PROSTHESIS ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER KWS MEDACTA INTERNATIONAL SA 04.01.0089 2344616 07630040713122

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention