MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; REVERSE LINER 40MM +6MM

Model Number	1365.50.820
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of production records for complained component has been performed and did not highlight any anomaly.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery has been performed on (b)(6) 2026, due to loosening of joint and dislocation.During the revision surgery pre-existing smr reverse liner +6mm dia.40mm (pn 1365.50.820, lot.24at3ve) has been explanted and replaced with smr reverse liner retentive +6mm dia.40mm (pn 1365.50.821).Surgery has been completed as intended.Previous surgery occurred on (b)(6) 2026.Patient date of birth is (b)(6) 1953.Event occurred in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: REVERSE LINER 40MM +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: 25134380
• Report Number: 3008021110-2026-00200
• Device Sequence Number: 13090316
• Product Code: PHX
• UDI-Device Identifier: 08033390102940
• UDI-Public: 8033390102940
• Combination Product (Y/N): N
• PMA/510(K) Number: K142139
• 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): 05/07/2026

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: 1365.50.820
• Device Lot Number: 24AT3VE
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2026
• 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: 72 YR
• Patient Sex: Unknown