MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; REVERSE LINERS 36MM (UHMWPE) RETENTIVE +6MM

Model Number	1361.50.820
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Loose body in joint (4926)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have been discarded therefore cannot be returned to manufacturer for analysis.Review of production records did not highlight any anomaly on complained component.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to disassembly of components.Previous surgery was performed on (b)(6) 2025.During original surgery following humeral components were implanted: finned stem dia 17 mm l.80 mm (pn 1304.15.170, lot.2422779, ster.2400186).Retentive liner + 6mm (pn 1361.50.820, lot.23at1lc, ster.2400073).140° humeral reverse body (pn 1352.15.011, lot.2500053, ster.2436410).In combination with glenoid components from another manufacturer.During revision the surgeon removed the above-mentioned retentive liner and replaced with extention and retentive reverse: retentive reverse liner (pn1360.54.816).Extension for humeral reverse body (pn 1352.15.001).Surgery was completed as intended.Event occurred in united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: REVERSE LINERS 36MM (UHMWPE) RETENTIVE +6MM
• 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: 24638848
• Report Number: 3008021110-2026-00145
• Device Sequence Number: 18588493
• Product Code: PHX
• UDI-Device Identifier: 08033390273640
• UDI-Public: 8033390273640
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• 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): 03/16/2026

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: 1361.50.820
• Device Lot Number: 23AT1LC
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2026
• 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 Sex: Unknown