MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; SMR TT METAL BACK BASEPLATE (TI6AL4V) - SMALL R

Model Number	1375.15.605
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Joint Laxity (4526); Loose body in joint (4926)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing record for batches of explanted components did not highlight any pre-existing anomaly or non-conformity that could have contributed to reported issue.The manufacturer will provide a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 due to glenoid failure.During revision, the following pre-existing shoulder prosthesis components were removed: smr glenoid baseplate small-r (pn 1375.15.605, lot 2511769, sterilization (b)(4)), smr glenoid peg tt small-r #m (pn 1375.14.652, lot 2514981, sterilization (b)(4)), smr connector small r (pn 1374.15.305, lot 2509762, sterilization (b)(4)), smr glenosphere ø 36mm (pn 1374.09.111, lot 2512612, sterilization (b)(4)), smr reverse liner + 6 mm (pn 1360.50.820, lot 24at5nv, sterilization (b)(4)).Surgeon converted the removed reverse assembly to an anatomic configuration implanting an adaptor 36mm for reverse body (pn 1352.15.200) and a cta head dia46mm (pn 1323.09.460).The surgery was completed as intended.Previous surgery is unknown.The patient is female, date of birth (b)(6) 1943.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: SMR TT METAL BACK BASEPLATE (TI6AL4V) - SMALL R
• 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: 24322374
• Report Number: 3008021110-2026-00063
• Device Sequence Number: 15930778
• Product Code: KWS
• UDI-Device Identifier: 08033390272797
• UDI-Public: 8033390272797
• Combination Product (Y/N): N
• PMA/510(K) Number: K133349
• 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: 1375.15.605
• Device Lot Number: 2511769
• 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