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

Model Number	1365.50.820
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 because patient dislocated.Previous surgery is unknown, as well as complete information of original assembly.During revision the surgeon removed the pre-existing smr reverse liner +6mm d.40mm (pn 1365.50.820) and implanted an extension for humeral reverse body (pn 1352.15.001) and a reverse liner +6mm dia40mm (pn 1365.54.820).Surgery was completed as intended to restore shoulder functionality.Patient is male, date of birth (b)(6) 1964.The event occurred in the united states.
Additional Manufacturer Narrative
Explanted component has been discarded therefore cannot be returned for identification and investigation.Review of manufacturing records cannot be performed because lot number is unknown.The manufacturer will submit a final report as soon as the investigation is completed.

• Brand Name: SMR SHOULDER
• 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: 24322377
• Report Number: 3008021110-2026-00065
• Device Sequence Number: 15944210
• 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 Explanted Year: 2025
• 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): 02/12/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2026
• 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