MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; SMR SHOULDER - TT AUGMENTED 360 BASEPLATE 7°; S-R; DIA.27 MM

Model Number	1375.15.507
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation a review of the device history records (dhrs) for the available lots was conducted.No pre-existing anomalies were identified among the devices manufactured within the same lots.This is the first and only complaint with these lots.A final mdr will be shared upon completion of the investigation.
Event or Problem Description
Revision of smr reverse shoulder arthroplasty performed on (b)(6) due to persistent pain.The surgeon attempted revision of the baseplate.The glenosphere, connector, screws, and baseplate were removed.The central peg remained in situ, as it was well fixed.The humeral component was retained in situ and no indication of infection was observed.The previous procedure had been performed on (b)(6) 2025.The following devices were explanted: smr rev.Hp lat.Liner medium (product code 1365.09.115, lot# 2403794, ster.(b)(4), smr connector small r (product code 1374.15.305, lot# 2432918, ster.(b)(4), smr reverse hp glenosph.40 mm (product code 1374.50.400, lot# 2500696, ster.(b)(4), tt augm.360 baseplate #s-r 7° (product code 1375.15.507, lot# 2319067, ster.(b)(4), bone screw ø6,5 h.25mm (product code 8420.15.020, lot# 2417486, ster.(b)(4), bone screw ø6,5 h.25mm (product code 8420.15.020, lot# 2436172, ster.(b)(4), bone screw ø6,5 h.30mm (product code 8420.15.030, lot# 2425715, ster.(b)(4).Patient is female 62 years old.Event happened in australia.

• Brand Name: SMR SHOULDER
• Common Device Name: SMR SHOULDER - TT AUGMENTED 360 BASEPLATE 7°; S-R; DIA.27 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24377893
• Report Number: 3008021110-2026-00136
• Device Sequence Number: 4941617
• Product Code: PHX
• UDI-Device Identifier: 08033390267854
• UDI-Public: 08033390267854
• Combination Product (Y/N): N
• PMA/510(K) Number: K191746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 1375.15.507
• Device Catalogue Number: 1375.15.507
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 06/22/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown