MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR TT AUGMENTED 360; SMR TT AUGMENTED 360 BASEPLATE S-R 19°X

Model Number	1375.15.569
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A shoulder revision surgery was performed on (b)(6) 2026.The metal back tt aug.360 baseplate #s-r 19°x (product code: 1375.15.569 - lot: unknown) become loose due to a fracture of the glenoid.The list of devices involved during revision: tt aug.360 baseplate #s-r 19°x (product code: 1375.15.569 - lot: unknown) - sold in us, smr glenoid peg tt small-r #m (product code: 1375.14.652 - lot: unknown) - sold in us, bone screw ø6,5 h.20mm (product code: 8420.15.010 - lot: unknown) - sold in us, bone screw ø6,5 h.25mm (product code: 8420.15.020 - lot: unknown) - sold in us.Event occurred in austria.
Additional Manufacturer Narrative
No review of manufacturing records for complained parts can be performed either since lot number of involved device tt aug.360 baseplate #s-r 19°x (product code: 1375.15.569 is unknown.

• Brand Name: SMR TT AUGMENTED 360
• Common Device Name: SMR TT AUGMENTED 360 BASEPLATE S-R 19°X
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 25297975
• Report Number: 3008021110-2026-00237
• Device Sequence Number: 15776563
• Product Code: PHX
• UDI-Device Identifier: 08033390180047
• UDI-Public: 08033390180047
• Combination Product (Y/N): N
• PMA/510(K) Number: K200171
• 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): 05/26/2026

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: 1375.15.569
• Device Catalogue Number: 1375.15.569
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 05/27/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown