MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SYSTEM; SMR SYSTEM - HUMERAL BODY REVERSE

Model Number	1352.15.010
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed on (b)(6) 2025.Patient had infection.The following components were involved in the event: smr reverse humeral body (part code 1352.15.010, lot number 2431460, sterilization (b)(4)); smr reverse liner + 3 mm (part code 1360.50.815, lot number 23at40h, sterilization (b)(4)).There were no delays in surgery, no pieces fragmented or broke, there was another device available, the surgery was completed as intended, and device was inspected prior to use.Previous surgery took place on (b)(6) 2025.The patient is a female, date of birth (b)(6) 1965.The event happened in the united states.
Additional Manufacturer Narrative
Checking the manufacturing and sterilization charts of the components involved in the event, no pre-existing anomaly has been discovered on the items belonging to the same lot numbers.We will submit a final mdr as soon as the investigation is complete.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR SYSTEM - HUMERAL BODY REVERSE
• 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: 21709129
• Report Number: 3008021110-2025-00022
• Device Sequence Number: 19968383
• Product Code: PHX
• UDI-Device Identifier: 08033390272568
• UDI-Public: 08033390272568
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 03/26/2025

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: 1352.15.010
• Device Lot Number: 2431460
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2025
• 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