MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SYSTEM; CONNECTOR WITH SCREW SMALL-STD

Model Number	1374.15.310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
By checking the dhr of the involved lots, no pre-existing anomaly has been found.This is the first and only complaint received on these lot numbers.A final report will be submitted once the investigation is complete.We submit a final mdr when the investigation is complete.
Event or Problem Description
Shoulder revision surgery performed on (b)(6) 2025 due to infection.The following devices were implanted in the previous surgery, performed on (b)(6) 2025: · smr reverse hp glenosphere 44 mm (product code 1374.50.440, lot #2512625 - ster.2500090) · smr reverse hp liner short (product code 1362.09.010, lot #2510318 - ster.2500108) · bone screw ø6.5 h.35mm (product code 8420.15.040, lot #2414295 - ster.2400126).Sold in us.· bone screw ø6.5 h.35mm (product code 8420.15.040, lot #2419835 - ster.2400171).Sold in us.· smr uncemented glenoid # std (product code 1375.20.010, lot #2510276 - ster.2500099) · smr reverse finned humeral body (product code 1352.15.050, lot #2504866 - ster.2500071).Sold in us.· smr connector small std (product code 1374.15.310, lot #2508622 - ster.2500087).Sold in us.· smr cemented revision stem ø15 mm (product code 1309.15.156, lot #1921189 - ster.2500108).Sold in us.Only the smr reverse hp glenosphere 44 mm and smr reverse hp liner short were explanted and replaced during the revision surgery.Patient is male, 73 years old.Event happened in australia.
Event or Problem Description
Shoulder revision surgery performed on (b)(6) 2025 due to infection.The following devices were implanted in the previous surgery, performed on (b)(6) 2025: · smr reverse hp glenosphere 44 mm (product code 1374.50.440, lot #2512625 - ster.(b)(4)).· smr reverse hp liner short (product code 1362.09.010, lot #2510318 - ster.(b)(4)).· bone screw ø6.5 h.35mm (product code 8420.15.040, lot #2414295 - ster.(b)(4)).Sold in us.· bone screw ø6.5 h.35mm (product code 8420.15.040, lot #2419835 - ster.(b)(4)).Sold in us.· smr uncemented glenoid # std (product code 1375.20.010, lot #2510276 - ster.(b)(4)).· smr reverse finned humeral body (product code 1352.15.050, lot #2504866 - ster.(b)(4)).Sold in us.· smr connector small std (product code 1374.15.310, lot #2508622 - ster.(b)(4)).Sold in us.· smr cemented revision stem ø15 mm (product code 1309.15.156, lot #1921189 - ster.(b)(4)).Sold in us.Only the smr reverse hp glenosphere 44 mm and smr reverse hp liner short were explanted and replaced during the revision surgery.Patient is male, 73 years old.Event happened in australia.
Additional Manufacturer Narrative
Investigation: checking the sterilization charts of the involved lots #, no pre-existing anomaly was found.All the products with those lot #s have been properly sterilized before being placed on the market.Device analysis: no physical analysis of the involved devices has been performed, as the explanted components were not returned to limacorporate.In the absence of returned parts, it is not possible to verify potential manufacturing defects, material anomalies, or signs of mechanical damage that could have contributed to the event.However, the review of sterilization and production records for the implicated lots did not reveal any deviations or anomalies that could indicate a product related issue.Based on the available information, the data do not support the conclusion that the infection related revision was caused by a defect in the device or its manufacturing process.Therefore, the available evidence suggests that the event cannot be attributed to a product related root cause, although the limited information prevents a definitive and exhaustive determination of the underlying cause.Pms data: over the past three years, 23 similar revision cases were reported out of 3985 smr reverse prostheses sold in australia (0.58%), and 51 similar events were reported out of (b)(4) units sold worldwide (0.06%).Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate continues monitoring the market to promptly detect any similar issue.Please note this is the final mdr.

• Brand Name: SMR SYSTEM
• Common Device Name: CONNECTOR WITH SCREW SMALL-STD
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 23692505
• Report Number: 3008021110-2025-00161
• Device Sequence Number: 9124042
• Product Code: PHX
• UDI-Device Identifier: 08033390271561
• UDI-Public: 08033390271561
• Combination Product (Y/N): Y
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 1374.15.310
• Device Catalogue Number: 1374.15.310
• 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: 12/02/2025
• Supplement Report FDA Received Date: 03/16/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown