MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; 140° FINNED REVERSE HUMERAL BODY

Model Number	1352.15.051
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of production records for involved component has been performed and did not highlight any anomaly nor non-conformity.A final report will be submitted as soon as investigation is completed.
Event or Problem Description
Revision surgery hereby reported has been performed on (b)(6) 2026, due to unknown reasons.Patient was originally implanted with smr reverse prosthesis.Original prosthetic assembly consisted of baseplate, lateralized connector +4mm, glenosphere eccentric dia 40mm and smr humeral body reverse (part number 1352.15.010, lot unknown).9/10 years later, first revision surgery occurred ((b)(6) 2025) due to infection: humeral body has been explanted and replaced with a new one (complaint associated to mfr # 3008021110-2026-00010).On january 21st, 2026, second revision surgery has been performed due to unknown reasons (mfr # 3008021110-2026-00241) and pre-existing humeral body and glenoid components has been explanted and replaced with new ones.A third revision surgery, hereby reported, occurred on (b)(6) 2026, and pre-existing humeral body and glenoid components except for the baseplate has been explanted and replaced, increasing also lateralization.Specifically, following components have been explanted: - 140° humeral body finned reverse (pn 1352.15.051, lot.2530378, ster.2500213); - reverse liner +3mm dia 40mm (pn 1365.50.815, lot.23at24a, ster.2400018); - glenosphere eccentrical dia 40mm (pn 1376.09.041, lot.2220948, ster.2200270); - connector + screw (pn 1374.15.305, lot.2501812, ster.2500045).And replaced with: - 140° humeral body reverse (pn 1352.15.015); - reverse liner retentive +3mm dia 40mm (pn 1356.54.816); - glenosphere eccentrical dia 40mm (pn 1376.09.041); - connector lat.+4mm + screw (pn 1374.15.314).Patient is male, date of birth (b)(6) 1962.Event occurred in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: 140° FINNED REVERSE HUMERAL BODY
• 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: 25278964
• Report Number: 3008021110-2026-00242
• Device Sequence Number: 13153698
• Product Code: PHX
• UDI-Device Identifier: 08033390268257
• UDI-Public: 8033390268257
• Combination Product (Y/N): N
• PMA/510(K) Number: K201905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/26/2026

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: 1352.15.051
• Device Lot Number: 2530378
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2026
• 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: 63 YR
• Patient Sex: Male