BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 24588555 · Received March 13, 2026

    Report

    Report Number
    3005180920-2026-00226
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 20, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706476
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 MAR 2026. LOT: 2210990: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 JUNE 2022. EXPIRATION DATE: 2027-JUNE-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION: APPROXIMATELY ONE YEAR AND THREE MONTHS AFTER THE PRIMARY SURGERY, RADIOGRAPHIC EXAMINATION CLEARLY DEMONSTRATES THE BREAKAGE OF ONE OF THE GLENOID SCREWS. THE FRACTURE OF THE SCREW IS VISIBLE ON THE X-RAY IMAGE AND MAY BE RELATED TO A MECHANICAL FAILURE AT THE LEVEL OF THE INFERIOR GLENOID FIXATION POINT. CAREFUL ASSESSMENT OF THE RADIOGRAPH ALSO SUGGESTS THAT THE GLENOSPHERE-BASEPLATE COMPLEX IS POSITIONED IN A SUBOPTIMAL ORIENTATION. THIS CONDITION IS LIKELY NOT RELATED TO THE INITIAL IMPLANTATION BUT MAY HAVE DEVELOPED PROGRESSIVELY OVER TIME DUE TO MECHANICAL FACTORS. A PLAUSIBLE MECHANISM FOR THE SCREW BREAKAGE IS INFERIOR HUMERAL-GLENOSPHERE IMPINGEMENT, WHICH CAN GENERATE ABNORMAL SHEAR AND ECCENTRIC LOADING FORCES ON THE INFERIOR PORTION OF THE GLENOID COMPONENT. REPETITIVE IMPINGEMENT IN THIS REGION MAY LEAD TO MICROMOTION, GRADUAL LOOSENING, AND INCREASED STRESS CONCENTRATION ON THE INFERIOR SCREW, ULTIMATELY RESULTING IN ITS FAILURE. THE AVAILABLE IMAGING SUGGESTS THAT IMPINGEMENT-RELATED FORCES MAY HAVE CONTRIBUTED BOTH TO THE SCREW BREAKAGE AND TO THE SUBSEQUENT DISPLACEMENT OF THE GLENOSPHERE-BASEPLATE CONSTRUCT INTO A SUBOPTIMAL POSITION. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THERE IS NO INDICATION OF A DEVICE MALFUNCTION. R&D ANALYSIS: THE ANTEROPOSTERIOR RADIOGRAPHIC IMAGE CONFIRMS THE BREAKAGE OF THE INFERIOR GLENOID FIXATION SCREW. ADDITIONALLY, A VISIBLE RADIOLUCENT GAP BETWEEN THE BASEPLATE BACK-SURFACE AND THE UNDERLYING BONE IS APPRECIABLE, SUGGESTING LOSS OF PRIMARY FIXATION WITH CONSEQUENT BASEPLATE MOBILIZATION (CRANIALIZATION). NOTABLY, THE ANGULAR ORIENTATION OF THE RETAINED MEDIAL FRAGMENT OF THE BROKEN SCREW IS DISCORDANT WITH THAT OF THE PROXIMAL PORTION IN CONTACT WITH THE BASEPLATE, FURTHER SUPPORTING THE HYPOTHESIS THAT BASEPLATE MICROMOTION OR DISPLACEMENT PRECEDED AND CONTRIBUTED TO THE MECHANICAL FAILURE OF THE GLENOID POLYAXIAL LOCKING SCREW - L26 (REF. 04.01.0160, LOT: 2210990). NO OTHER EVENTS HAVE BEEN REPORTED FOR LOT: 2210990, WHICH COMPRISES (B)(4) DISTRIBUTED UNITS, THUS SUGGESTING THAT MANUFACTURING OR PROCESS DEFECTS CAN BE EXCLUDED. CONSIDERING THE OVERALL POST-MARKET SURVEILLANCE DATA FOR SHOULDER POLYAXIAL GLENOID SCREWS, THE OCCURRENCE RATE FOR NON-TRAUMATIC SCREW BREAKAGE STANDS AT (B)(4) INDICATING THAT THIS FAILURE MODE REMAINS STATISTICALLY RARE. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. THERE IS NO INDICATION THAT A DEVICE MALFUNCTION MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY MANUFACTURING-RELATED ISSUES. THE SCREW BREAKAGE IS MOST LIKELY RELATED TO PROGRESSIVE MECHANICAL OVERLOAD AT THE INFERIOR GLENOID FIXATION POINT, POSSIBLY ASSOCIATED WITH BASEPLATE MICROMOTION AND INFERIOR HUMERAL-GLENOSPHERE IMPINGEMENT OVER TIME.

    Description of Event or Problem · 0

    APPROXIMATELY 1 YEAR AND 3 MONTHS AFTER THE PRIMARY SURGERY, X-RAYS CLEARLY SHOWED THE BREAKAGE OF ONE GLENOID SCREW. A REVISION SURGERY HAS BEEN SCHEDULED BUT HAS NOT YET BEEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614735 SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L26 PHX MEDACTA INTERNATIONAL SA 04.01.0160 2210990 07630040706476

    Patients

    Seq Age Sex Outcome Treatment
    1