MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; GLENOSPHERE DIA. 36 MM

Model Number	1374.09.111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have been discarded therefore cannot be returned to manufacturer for identification and analysis.Lot number is unknown thus no review of manufacturing records for involved components can be performed.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery occurred on (b)(6) 2026 as patient presented post-op pain.During revision the surgeon removed and replaced following pre-existing components: - smr cementless finned stem (pn 1304.15.150).- smr reverse humeral body (pn 1352.15.010).- smr reverse liner standard (pn 1360.50.810).- smr glenosphere ø 36mm (pn 1374.09.111).- smr connector small r (pn 1374.15.305).Surgery was completed as intended.Patient is male, date of birth (b)(6) 1947.Event occurred in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: GLENOSPHERE DIA. 36 MM
• 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: 24638410
• Report Number: 3008021110-2026-00150
• Device Sequence Number: 15954663
• Product Code: PHX
• UDI-Device Identifier: 08033390272230
• UDI-Public: 8033390272230
• Combination Product (Y/N): N
• PMA/510(K) Number: K163397
• 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): 03/17/2026

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: 1374.09.111
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2026
• 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 Age: 79 YR
• Patient Sex: Male