MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SYSTEM; SMR SYSTEM - GLENOSPHERE ECCENTRICAL DIA. 36 MM

Model Number	1376.09.031
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of the removed components, no pre-existing anomaly was discovered in the items belonging to the same product codes and lot numbers as the devices involved in this complaint.The manufacturer will submit a final mdr as soon as the investigation is complete.
Event or Problem Description
Shoulder revision surgery was performed on (b)(6) 2025, due to dislocation.The patient was dislocating and the surgeon decided to implant a lateralized glenosphere and a +3 retentive poly.The following components were removed: - smr rever.Liner retentive std (part code 1361.50.810, lot number 20at18s, sterilization unknown).- smr connector small r (part code 1374.15.305, lot number 2432915, sterilization (b)(4)).- smr eccent.Glenosphere ø 36mm (part code 1376.09.031, lot number 2433704, sterilization (b)(4)).Previous surgery performed on (b)(6) 2025.The patient is a male, date of birth (b)(6) 1952.The event happened in the united states.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR SYSTEM - GLENOSPHERE ECCENTRICAL DIA. 36 MM
• 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: 22458718
• Report Number: 3008021110-2025-00089
• Device Sequence Number: 8383707
• Product Code: MBF
• UDI-Device Identifier: 08033390272339
• UDI-Public: 08033390272339
• Combination Product (Y/N): N
• PMA/510(K) Number: K163397
• 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): 07/09/2025

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: 1376.09.031
• Device Lot Number: 2433704
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2025
• 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; Required Intervention
• Patient Sex: Male