MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; REVERSE LINER 40MM +3MM

Model Number	1365.50.815
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of production records did not highlight any anomaly nor non-conformity on lot number involved (23at24a).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 shoulder dislocation.Pre-existing following components has been explanted: smr reverse liner +3mm d.40mm (part number 1365.50.815, lot.23at24a, ster.2400018); smr glenosphere ø 40mm (part number 1374.09.121, lot.2415894, ster.2400152); smr connector small r (part number 1374.15.305, lot.2325339, ster.2300250); and replaced with new following ones: smr reverse liner retentive +3mm d.40mm (part number 1365.50.816); smr glenosphere ø 40mm (part number 1374.09.121); smr connector lat.+4mm small r (part number 1374.15.314).Previous surgery has been performed on (b)(6) 2024.Patient is male, date of birth (b)(6) 1943.Event occurred in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: REVERSE LINER 40MM +3MM
• 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: 25687433
• Report Number: 3008021110-2026-00253
• Device Sequence Number: 15880437
• Product Code: PHX
• UDI-Device Identifier: 08033390102933
• UDI-Public: 8033390102933
• Combination Product (Y/N): N
• PMA/510(K) Number: K142139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/01/2026

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: 1365.50.815
• Device Lot Number: 23AT24A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2026
• 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: 82 YR
• Patient Sex: Male