MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.19MM

Model Number	1304.15.190
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of production records has been performed and did not highlight any anomaly nor non-conformity on involved components.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery occurred on (b)(6) 2026, due to glenoid bone loss and stem loosening.Previous surgery was performed on (b)(6) 2025.During original surgery following humeral components were implanted: finned stem dia.19 mm l.80mm (pn: 1304.15.190, lot: 2513645, ster.2500096).140° humeral body reverse (pn: 1352.15.011, lot: 2513035, ster.2500105).Extension for humeral reverse body (pn: 1352.15.001, lot: 2430343, ster.2400276).Smr reverse liner +3mm (pn: 1360.50.815, lot: 21at277, ster.2200049).In combination with glenoid components from another manufacturer.During revision the surgeon explanted the whole assembly, both glenoid and humeral components, that were replaced with glenoid from other manufactured and same humeral components with the exception of a thicker finned stem and a thicker liner, below detailed: finned stem dia.20 mm l.80mm (pn: 1304.15.200).Smr reverse liner +6mm (pn: 1360.50.820).Surgery was completed as intended.Patient is male, date of birth on (b)(6) 1961.Event occurred in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.19MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale, 52; villanova di san daniele, udine 33038
• MDR Report Key: 24950301
• Report Number: 3008021110-2026-00183
• Device Sequence Number: 12081798
• Product Code: HSD
• UDI-Device Identifier: 08033390270823
• UDI-Public: 8033390270823
• Combination Product (Y/N): N
• PMA/510(K) Number: K101263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1304.15.190
• Device Lot Number: 2513645
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male