MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; REVERSE LINER 40MM STANDARD

Model Number	1365.50.810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026, due to patient complaint of pain.Original surgery occurred on (b)(6) 2025, and following components were implanted: - smr glenoid peg tt small-r #m (pn 1375.14.652, lot.2424760, ster.(b)(4)); - smr connector small r (pn 1374.15.305, lot.2126602, ster.(b)(4)); - tt augm.360 baseplate #s-r 15° (pn 1375.15.515, lot.2100640, ster.(b)(4)); - smr glenosphere ø 40mm (pn 1374.09.121, lot.2427991, ster.(b)(4)); - smr reverse liner std d.40mm (pn 1365.50.810, lot.23at40k, ster.(b)(4)); - smr reverse finned humeral body (pn 1352.15.050, lot.2023455, ster.(b)(4)); - smr cem.Revision stem ø15 mm (pn 1309.15.158, lot.1520565, ster.(b)(4)).During revision surgery, hereby reported, the pre-existing humeral body, reverse liner, connector and glenosphere were removed and replaced with: - smr 140° humeral body finned reverse (pn 1352.15.051); - extension for humeral reverse body (pn 1352.15.001); - smr reverse liner retentive std dia.40 mm (pn1365.50.811); - smr connector lat +2mm + screw (pn 1374.15.312); - glenosphere dia 40 mm (pn 1374.09.121).Surgery has been completed as intended.Patient is male, date of birth (b)(6) 1951.Event occurred in the united states.
Additional Manufacturer Narrative
Explanted components have not been returned to manufacturer therefore cannot be analysed.Review of production and sterilization records for revised components has been performed and did not highlight any anomaly or non-conformity that could have contributed to the issue.The manufacturer will submit a final report as soon as the investigation is completed.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: REVERSE LINER 40MM STANDARD
• 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: 24813211
• Report Number: 3008021110-2026-00173
• Device Sequence Number: 6027620
• Product Code: PHX
• UDI-Device Identifier: 08033390102919
• UDI-Public: 8033390102919
• Combination Product (Y/N): N
• PMA/510(K) Number: K142139
• 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): 04/07/2026

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: 1365.50.810
• Device Lot Number: 23AT40K
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2026
• 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: 74 YR
• Patient Sex: Male