MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SYSTEM; SMR SYSTEM - FINNED STEM DIA. 15 MM L. 80 MM

Model Number	1304.15.150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Initial report (b)(4).Revision surgery performed on (b)(6) 2026 due to infection.The implanted devices were removed and spacer inserted while infection resolves.Previous surgery performed on (b)(6) 2022.The following devices were explanted: smr cementless finned stem (product code: 1304.15.150, lot: 2119081 - ster: (b)(6)) - sold in us.Smr reverse humeral body (product code: 1352.20.010, lot:2124103 - ster: (b)(6)) - not sold in us smr reverse hp liner long (product code: 1362.09.020, lot: 2116715 - ster: (b)(6)) - sold in us smr connector small r (product code: 1374.15.305, lot: 2201510 - ster: 2200042) - sold in us smr reverse hp glenosph.44 mm (product code: 1374.50.440, lot: 2122191 - ster: (b)(6)) - sold in us smr uncement.Glenoid #small-r (product code: 1375.20.005, lot: 2124096 - ster: (b)(6)) - not sold in us bone screw ø6,5 h.25mm (product code: 8420.15.020, lot: 2024416 - ster: (b)(6)) - sold in us bone screw ø6,5 h.30mm (product code: 8420.15.030, lot:2106481 - ster: (b)(6)) - sold in us patient is a female, 60 years old.Event occurred in canada.
Additional Manufacturer Narrative
The review of the dhrs and sterilization charts for the involved lot numbers was completed and did not reveal any pre existing anomalies.The dhr check for lot number 2119081 has been requested from the third party supplier and is currently ongoing.A final report will be provided upon completion of the investigation.
Event or Problem Description
Initial report (b)(4).Revision surgery performed on (b)(6) 2026 due to infection.The implanted devices were removed and spacer inserted while infection resolves.Previous surgery performed on (b)(6) 2022.The following devices were explanted: smr cementless finned stem (product code: 1304.15.150, lot: 2119081 - ster:2100290) - sold in us.Smr reverse humeral body (product code: 1352.20.010, lot:2124103 - ster: 2200005) - not sold in us.Smr reverse hp liner long (product code: 1362.09.020, lot: 2116715 - ster: 2100288) - sold in us.Smr connector small r (product code: 1374.15.305, lot: 2201510 - ster: 2200042) - sold in us.Smr reverse hp glenosph.44 mm (product code: 1374.50.440, lot: 2122191 - ster: 2100323) - sold in us.Smr uncement.Glenoid #small-r (product code: 1375.20.005, lot: 2124096 - ster: 2200010) - not sold in us.Bone screw ø6,5 h.25mm (product code: 8420.15.020, lot: 2024416 - ster: 2100030) - sold in us.Bone screw ø6,5 h.30mm (product code: 8420.15.030, lot:2106481 - ster: 2100198) - sold in us.Patient is a female, 60 years old.Event occurred in canada.
Additional Manufacturer Narrative
A review of the device history records (dhrs) and the sterilization charts for the involved lot number was performed and did not reveal any pre existing anomalies.The additional information requested from the complaint source, including pre- and post operative x rays, patient clinical information, and microbiological tests or their outcomes, was not provided.Therefore, based on the limited information available, a definitive root cause of the event cannot be determined.However, based on the review of the dhrs for the involved lot numbers, which did not reveal any anomalies, it is concluded that the event is not a product-related issue.Pms data (b)(4).This is a final mdr report.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR SYSTEM - FINNED STEM DIA. 15 MM L. 80 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24444030
• Report Number: 3008021110-2026-00151
• Device Sequence Number: 10443598
• Product Code: HSD
• UDI-Device Identifier: 08033390270786
• UDI-Public: 08033390270786
• Combination Product (Y/N): N
• PMA/510(K) Number: K101263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 04/15/2026

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: 1304.15.150
• Device Catalogue Number: 1304.15.150
• Device Lot Number: 2119081
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/17/2026
• 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