BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMIC SHOULDER PROSTHESIS

    MDR report key: 24494913 · Received March 3, 2026

    Report

    Report Number
    3005180920-2026-00181
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    February 12, 2026
    Report Date
    March 3, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040713276
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 FEB 2026. ANATOMICAL SHOULDER SYSTEM 04.01.0132 HC PEGGED GLENOID D 48 (K170910) LOT: 183731: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-AUG-2018. EXPIRATION DATE: 19-JUL-2023. 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. ANATOMICAL SHOULDER SYSTEM 04.01.0095 METAL HUMERAL HEAD D 50 (K170910) LOT: 1710142: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2018. EXPIRATION DATE: 14-MAY-2023. 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. ANATOMICAL SHOULDER SYSTEM 04.01.0028 HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135 & DEG; -11 (K170910) LOT: 1710039: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAY-2018. EXPIRATION DATE: 21-MAY-2023. 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. ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER (K170910) LOT: 185295: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-DEC-2018. EXPIRATION DATE: 25-NOV-2023. 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. R&D ANALYSIS: THE PATIENT UNDERWENT LEFT SHOULDER REVISION SURGERY TO A REVERSE SYSTEM APPROXIMATELY 6.5 YEARS AFTER PRIMARY ANATOMIC ARTHROPLASTY DUE TO PAIN AND REDUCED RANGE OF MOTION. DURING REVISION, THE ROTATOR CUFF WAS FOUND TO BE DEGENERATIVE. THE CEMENTED PEGGED GLENOID COMPONENT WAS WELL POSITIONED, WELL FIXED, AND REQUIRED SIGNIFICANT EFFORT TO REMOVE. HOWEVER, THE EXPLANTED GLENOID SHOWED NOTABLE DAMAGE, INCLUDING A POSTERIOR-INFERIOR WEAR PATTERN AND A & QUOT; CHIPPED & QUOT; SECTION THAT THE SURGICAL TEAM BELIEVES WAS NOT CAUSED DURING REMOVAL. NO IMPINGEMENT WAS NOTED, BUT OSTEOLYSIS WAS OBSERVED. BASED ON THE PICTURES AND INFORMATION PROVIDED, THERE IS NO CLEAR EVIDENCE OF AN IMPLANT-RELATED DEFECT OR FAILURE. THE LONG DURATION IN VIVO AND THE WELL-FIXED STATUS OF THE GLENOID SUGGEST A TIME-DEPENDENT, BIOLOGICAL, OR BIOMECHANICAL PROCESS. THE OBSERVED OSTEOLYSIS IS CONSISTENT WITH A BIOLOGIC RESPONSE TO PARTICULATE DEBRIS OR CHRONIC MECHANICAL LOADING. FURTHERMORE, THE POSTERIOR-INFERIOR DAMAGE MAY REFLECT PATIENT-SPECIFIC BIOMECHANICS, SUCH AS ECCENTRIC LOADING DUE TO ROTATOR CUFF DEGENERATION, RATHER THAN AN INHERENT DEVICE ISSUE. THE EVENT IS PRELIMINARILY ASSESSED AS NOT IMPLANT-RELATED, AS THERE IS NO EVIDENCE OF A MANUFACTURING DEFECT OR DEVICE MALFUNCTION. THE FINDINGS ARE MOST CONSISTENT WITH LONG-TERM, IN-VIVO WEAR AND PATIENT-SPECIFIC FACTORS. ROOT CAUSE: THE MOST LIKELY ROOT CAUSE IS LONG-TERM IN VIVO WEAR ASSOCIATED WITH PATIENT-SPECIFIC BIOMECHANICAL FACTORS, INCLUDING ROTATOR CUFF DEGENERATION AND ECCENTRIC LOADING, LEADING TO OSTEOLYSIS AND PROGRESSIVE GLENOID BASEPLATE DAMAGE. NO EVIDENCE OF A MANUFACTURING DEFECT OR DEVICE MALFUNCTION WAS IDENTIFIED.

    Description of Event or Problem · 0

    LEFT SHOULDER REVISION SURGERY DUE TO PAIN AND RESTRICTION OF MOVEMENT ABOUT 6.5 YEARS AFTER THE PRIMARY SURGERY. OSTEOLYSIS WAS ALSO NOTED. REVERSE SYSTEM IMPLANTED; ROTATOR CUFF WAS DEGENERATIVE BUT REPAIRABLE WHEN COMPLETING THE REVERSE. THE PE PEGGED GLENOID WAS FOUND VERY DAMAGED IN THE POSTERIOR INFERIOR SURFACE (DESPITE BEING FOUND WELL FIXED AND NO IMPINGEMENT WAS OBSERVED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558809 ANATOMIC SHOULDER PROSTHESIS HC PEGGED GLENOID Ø48 KWS MEDACTA INTERNATIONAL SA 04.01.0132 183731 07630040713276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention