MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; REVERSE LINER 40MM +6MM

Model Number	1365.50.820
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing and sterilization records for involved product did not highlight any pre-existing anomaly or non-conformity relevant to the 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) 2026 due to disassembly of reverse liner.Previous surgery occurred on december 30th 2025 when the following smr reverse configuration was implanted: - smr connector small std (part number 1374.15.310, lot 2500908, sterilization (b)(4)), - smr glenosphere ø 40mm (part number 1374.09.121, lot 2501638, sterilization (b)(4)), - smr reverse humeral body short (part number 1352.15.005, lot 2507908, sterilization (b)(4)), - smr reverse liner +6mm d.40mm (part number 1365.50.820, lot 24at3ve, sterilization (b)(4)).During revision the above-mentioned liner was removed and replaced with a new thinner reverse liner +3mm dia40mm (pn 1365.50.815).Surgery was completed as intended.The patient is male, date of birth (b)(6) 1960.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE LINER 40MM +6MM
• 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: 24531027
• Report Number: 3008021110-2026-00128
• Device Sequence Number: 21066268
• Product Code: PHX
• UDI-Device Identifier: 08033390102940
• UDI-Public: 8033390102940
• Combination Product (Y/N): N
• PMA/510(K) Number: K142139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/06/2026

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: 1365.50.820
• Device Lot Number: 24AT3VE
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2026
• 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: 65 YR
• Patient Sex: Male