MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; REVERSE LINER DIA.36MM, +6MM

Model Number	1360.54.820
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing records did not highlight any anomaly or non-conformity.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.In order to create stability, during the revision pre-existing reverse liner +6 mm d.36 mm (pn: 1360.54.820, lot: 24at62p, ster: 2500100) has been explanted and replaced with retentive reverse liner +3mm dia 36mm (pn: 1360.54.816), and an extension for humeral reverse body +9mm (pn: 1352.15.001) has been implanted.Previous surgery is unknown.Patient is female, date of birth on (b)(6) 1959.Event occurred in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: REVERSE LINER DIA.36MM, +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: 25239088
• Report Number: 3008021110-2026-00220
• Device Sequence Number: 9490441
• Product Code: PHX
• UDI-Device Identifier: 08033390268219
• UDI-Public: 8033390268219
• Combination Product (Y/N): N
• PMA/510(K) Number: K220792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1360.54.820
• Device Lot Number: 24AT62P
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2026
• 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: 66 YR
• Patient Sex: Female