MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SYSTEM; SMR REVERSE HP GLENOSPHERE 40MM

Model Number	1374.50.400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Scar Tissue (2060); Medical device site infection (4845)
Date of Event	09/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Shoulder revision surgery of a smr reverse prostheses performed on (b)(6) 2025, due to possible infection and arthrofibrosis with stiffness.Removal of glenosphere and reverse body and putting in a new 140-degree humeral body, humeral liner and 40 mm glenosphere.The following devices were explanted: smr reverse humeral body (product code 1352.20.010, lot # 2419882- ster.2400171).Smr reverse hp liner medium (product code 1362.09.015, lot #2228636 - ster.2300040) sold in us.Smr reverse hp glenosphere 44 mm (product code 1374.50.440, lot # 2425153- ster.2400204) sold in us.Bone screw ø6,5 h.25mm (product code 8420.15.020, lot #2330524- ster.2300285) sold in us the previous surgery was performed on (b)(6) 2024.Event happened in australia.
Additional Manufacturer Narrative
Investigation: checking the sterilization charts of the involved lots #2419882, #2412566 #2425153 and #2330524, no pre-existing anomaly was found.This is the first and only complaint received on this lots #.We submit a final mdr when the investigation is complete.
Additional Manufacturer Narrative
Investigation: checking the dhr of the involved lots #2419882, #2412566 #2425153 and #2330524, no pre-existing anomaly was found.This is the first and only complaint received on this lots #.Device analysis.Devices involved were not returned to limacorporate for further analysis.Checking the sterilization charts of the components removed in the revision surgery hereby reported, no preexisting anomaly that could have contributed to this event has been discovered.In conclusion, we cannot determine the exact root cause of the event.However, base on: - the sterilization charts of the lot numbers involved were checked and no pre-existing anomalies were found.- this is the first and only complaint received on the lot numbers involved.- no additional information is available regarding this event; therefore, we are not able to carry out any further investigation.We may conclude the event as not product related.Pms data: (b)(4) similar events from (b)(4) units sold in australia (b)(4) in the past 3 years.(b)(4) similar events from (b)(4) units sold worldwide (b)(4) in the past 3 years.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions are required for this specific case.Limacorporate continues monitoring the market to promptly detect any further similar issue.This is the final mdr.
Event or Problem Description
Shoulder revision surgery of a smr reverse prostheses performed on (b)(6) 2025, due to possible infection and arthrofibrosis with stiffness.Removal of glenosphere and reverse body and putting in a new 140-degree humeral body, humeral liner and 40 mm glenosphere.The following devices were explanted: · smr reverse humeral body (product code 1352.20.010, lot # 2419882- ster.(b)(4)) - sold in us.· smr reverse hp liner medium (product code 1362.09.015, lot #2228636 - ster.(b)(4)).· smr reverse hp glenosphere 44 mm (product code 1374.50.440, lot # 2425153- ster.(b)(4)) - sold in us.· bone screw ø6,5 h.25mm (product code 8420.15.020, lot #2330524- ster.(b)(4)) - sold in us the previous surgery was performed on (b)(6) 2024.Event happened in australia.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR REVERSE HP GLENOSPHERE 40MM
• 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: 23130496
• Report Number: 3008021110-2025-00129
• Device Sequence Number: 21156685
• Product Code: PHX
• UDI-Device Identifier: 08033390061230
• UDI-Public: 08033390061230
• Combination Product (Y/N): Y
• PMA/510(K) Number: K243826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: 1374.50.400
• Device Catalogue Number: 1374.50.400
• Device Lot Number: 2425153
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 11/20/2025
• 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: Other
• Patient Sex: Unknown