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

Model Number	1374.09.120
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of the devices removed in the revision surgery hereby reported, no pre-existing anomaly was discovered in the items belonging to the same lot number and sterilization number as the components involved in this event.The manufacturer will submit a final mdr as soon as the investigation is complete.
Event or Problem Description
Shoulder revision surgery performed on (b)(6) 2025, due to chronic dislocation.The reverse implant was replaced by hemi.Date of previous surgery is unknown.The following components were removed: - smr humeral extension + 9 mm (part code 1352.15.001, lot number 2313276, sterilization (b)(4)).- smr reverse liner retentive (part code 1365.50.821, lot number 23at3bw, sterilization (b)(4)).- smr glenosphere ø40mm (part code 1374.09.120, lot number 1506088, sterilization (b)(4)).- smr metal-back glenoid std (part code 1375.21.010, lot number 1617881, sterilization (b)(4)).The above-mentioned devices were replaced by the following new ones: - smr adaptor for reverse body (part code 1352.15.200, lot number 2410001, sterilization (b)(4)).- smr extension for reverse humeral body (part code 1352.15.001, lot number 2515817, sterilization (b)(4)).- smr cta head (part code 1323.09.460, lot number 2517496, sterilization (b)(4)).The patient is a male, date of birth (b)(6) 1944.The event happened in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: GLENOSPHERE
• 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: 23390078
• Report Number: 3008021110-2025-00137
• Device Sequence Number: 21343835
• Product Code: PHX
• UDI-Device Identifier: 08033390102995
• UDI-Public: 8033390102995
• Combination Product (Y/N): N
• PMA/510(K) Number: K142139
• 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,Followup
• Report Date (Section B): 07/03/2026

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: 1374.09.120
• Device Lot Number: 1506088
• 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: 10/27/2025
• Supplement Report FDA Received Date: 07/03/2026
• 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: 80 YR
• Patient Sex: Male