MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR TT AUGMENTED 360; SMR TT AUGMENTED 360 BASEPLATE S-R 15°X

Model Number	1375.15.565
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026, with removal of the glenoid component due to loosening and implant dislocation.All components were explanted, with the exception of the uncemented humeral stem, which remained implanted.Wear was observed on the glenoid tt peg, probably caused by scraping from the lateralized inlay after failure of glenoid components.The patient had previously undergone surgery on (b)(6) 2025 (our complaint reference (b)(4)), which was the first revision procedure of a primary reverse shoulder arthroplasty (rsa) performed on (b)(6) 2023, due to loosening of the glenoid components.The following devices were explanted during the revision surgery on (b)(6) 2026: · smr reverse hp glenosph.40 mm (product code: 1374.50.400, lot: 2517230 - ster: (b)(6)) - sold in us.· tt augm.360 baseplate s-r 15°x (product code: 1375.15.565, lot: 2517898 - ster: (b)(6)) - sold in us · smr reverse humeral body short (product code:1352.15.005, lot:2422027 - ster: (b)(6)) - sold in us · smr rev.Hp lat.Liner medium(product code:1365.09.115, lot:2519411 - ster: (b)(6)) - sold in us · smr connector small r (product code:1374.15.305, lot: 2523844 - ster: (b)(6)) - sold in us event occurred in belgium.
Additional Manufacturer Narrative
The device history records (dhrs) of the involved lot numbers 2517230 and 2517898 were reviewed and no pre-existing anomalies were identified in the manufactured devices.This is the first and only complaint received for these lot numbers.A final report will be submitted once the investigation has been completed.

• Brand Name: SMR TT AUGMENTED 360
• Common Device Name: SMR TT AUGMENTED 360 BASEPLATE S-R 15°X
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24581096
• Report Number: 3008021110-2026-00154
• Device Sequence Number: 13360109
• Product Code: PHX
• UDI-Device Identifier: 08033390180337
• UDI-Public: 08033390180337
• Combination Product (Y/N): N
• PMA/510(K) Number: K200171
• 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): 03/09/2026

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: 1375.15.565
• Device Catalogue Number: 1375.15.565
• Device Lot Number: 2517898
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/12/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown