MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SYSTEM; SMR SYSTEM - REVERSE LINER +3MM

Model Number	1360.50.815
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Shoulder revision surgery performed on (b)(6) 2025, due to infection.The following glenosphere, connector and reverse liner were removed and replaced by new components: smr reverse liner + 3 mm (part code 1360.50.815, lot number 24at5p7, sterilization (b)(4)).Smr connector small r (part code 1374.15.305, lot number 2432923, sterilization (b)(4)).Smr eccent.Glenosphere ø 36mm (part code 1376.09.031, lot number 2434937, sterilization (b)(4)).The other components previously implanted were left in situ: smr cementless mini stem (part code 1304.15.120, lot number 2223142, sterilization (b)(4)).Smr reverse humeral body short (part code 1352.15.005, lot number 2435343, sterilization (b)(4)).Smr metal-back glenoid small r (part code 1375.21.005, lot number 2426024, sterilization (b)(4)).Previous surgery took place on (b)(6) 2025.The patient is a female, 52 years old.The event happened in the united states.
Additional Manufacturer Narrative
Investigation: checking the manufacturing and sterilization charts, no pre-existing anomaly was discovered in the items belonging to the same part codes and lot numbers as the components involved in this event.According to the available records, this is the first and only complaints received on those lot numbers.Neither removed devices, nor x-rays and additional information on the pathogen involved in the infection are available to be shared with the manufacturer.Therefore, no further investigation can be carried out on this case.However, taking into account that: no pre-existing anomalies were found on the items belonging to the same part codes and lot numbers as the devices involved in this event, by checking the manufacturing and sterilization charts.We have no evidence to consider the event as product-related.Pms data: based on the relevant pms data, the revision rate of the smr reverse liners belonging to the families 1360.50.Xxx, 1361.50.Xxx, 1365.50.Xxx due to infection is around 0.06%.Based on the root cause analysis performed and according to the relevant pms data, no corrective action is required for this specific case.The manufacturer will continue monitoring the market to promptly detect any further similar issue.Note: this is a combined initial-final mdr.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR SYSTEM - REVERSE LINER +3MM
• 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: 22115063
• Report Number: 3008021110-2025-00066
• Device Sequence Number: 7156909
• Product Code: PHX
• UDI-Device Identifier: 08033390273602
• UDI-Public: 08033390273602
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 05/30/2025

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: 1360.50.815
• Device Lot Number: 24AT5P7
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2025
• 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 Sex: Unknown