MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SYSTEM; SMR SYSTEM - REVERSE HP LINER SHORT DIA. 40MM

Model Number	1365.09.010
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint source reported a shoulder revision surgery performed on (b)(6) 2026.Patient suffered a dislocation.Instability was indicated.Previous surgery performed on (b)(6) 2025.Patient: male, 65 years old.The following complaints were explanted: smr reverse hp liner short (product code: 1365.09.010, lot: 2304712 - ster: (b)(4), smr cementless finned stem (product code: 1304.15.180, lot: 2204389 - ster: (b)(4) smr reverse finned humer.Body (product code:1352.15.050, lot:2307216 - ster: (b)(4), smr connector small r (product code: 1374.15.305, lot: 2308335 - ster: (b)(4), smr reverse hp glenosph.40 mm (product code: 1374.50.400, lot: 2411197 - ster: (b)(4), cortic.Bone screw d.5 l.28 mm (product code: 8432.15.028, lot: 2315144 - ster: (b)(4), cortic.Bone screw d.5 l.28 mm (product code: 8432.15.028, lot: 2403889 - ster: (b)(4), smr uncement.Glenoid #small-r (product code: 1375.20.005 , lot: 2308818 - ster: (b)(4).Event occurred in canada.
Additional Manufacturer Narrative
The review of the device history records (dhrs) of lot number involved 2304712 did not highlight any pre-existing anomalies.This is the first and only complaint received on lot number 2304712.A final report will be submitted after the investigation is completed.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR SYSTEM - REVERSE HP LINER SHORT DIA. 40MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24995510
• Report Number: 3008021110-2026-00205
• Device Sequence Number: 9033987
• Product Code: PHX
• UDI-Device Identifier: 08033390061254
• UDI-Public: 08033390061254
• Combination Product (Y/N): N
• PMA/510(K) Number: K243826
• 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): 04/27/2026

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: 1365.09.010
• Device Catalogue Number: 1365.09.010
• Device Lot Number: 2304712
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/27/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown