MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; SMR SHOULDER - CONNECTOR LAT +2 MM + SCREW SMALL / STD

Model Number	1374.15.322
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the sterilization charts of the involved lots#: 2114644, #: 2412566 and #: 2410886, 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: items involved are not returning to limacorporate for further analysis.No additional details were available on this post-operative issue, specifically pre-operative x-rays related to the revision surgery were asked, but not available.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering that: check of sterilization charts highlighted no anomalies on the components involved.According to the received information, cultures were positive for p.Acnes.The patient is asa 3.We cannot go back with certainty to the root cause of the event, but we can state that it was not product related.Pms data.According to limacorporate pms data, the revision rate of smr reverse prostheses due to infection is (b)(4).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.Note: this is a combined initial-final mdr.
Event or Problem Description
Shoulder revision surgery of a smr reverse prostheses performed on (b)(6) 2024, due to deep infection.A washout was performed on (b)(6), then a formal dair was done on (b)(6) 2024.During the dair procedure, the following devices were explanted: smr reverse hp lateralizing liner long (product code: 1362.09.120, lot#: 2114644 - ster.2100274) - product not sold in the us.Smr small/std connector +2 (product code: 1374.15.322, lot#: 2412566 - ster.2400120).Smr reverse hp glenosphere 44 mm (product code: 1374.50.440, lot#: 2410886 - ster.2400092) product not sold in the us.Organism cultured p.Acnes.Devices of same sizes were implanted.Previous surgery on (b)(6) 2024.Patient is a male, 74 years old, asa 3.Event happened in australia.

• Brand Name: SMR SHOULDER
• Common Device Name: SMR SHOULDER - CONNECTOR LAT +2 MM + SCREW SMALL / STD
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 21091081
• Report Number: 3008021110-2024-00100
• Device Sequence Number: 9105798
• Product Code: PHX
• UDI-Device Identifier: 08033390268073
• UDI-Public: 08033390268073
• Combination Product (Y/N): N
• PMA/510(K) Number: K183042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 11/19/2024

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: 1374.15.322
• Device Catalogue Number: 1374.15.322
• Device Lot Number: 2412566
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2025
• 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: Other
• Patient Sex: Unknown