MAUDE Adverse Event Report: Limacorporate S.p.A. SMR Shoulder System; Reverse Liner 40mm +3mm

Model Number	1365.50.815
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed on (b)(6) 2025, due to implant dislocation.Patient dislocated twice.The following liner and glenosphere were removed and the surgeon put in a lateralized glenosphere and a larger retentive poly: smr reverse liner +3mm d.40mm (part code 1365.50.815, lot number 23at24a, sterilization (b)(4), smr eccent.Glenosphere ø 40mm (part code 1376.09.041, lot number 2307061, sterilization (b)(4).Previous surgery took place on (b)(6) 2025.The patient is a male, date of birth (b)(6) 1955.The event happened in the united states.
Additional Manufacturer Narrative
Checking the manufacturing charts of the components involved in the event, no pre-existing anomaly has been discovered in the items belonging to the same lot numbers as the device removed.We will submit a final mdr as soon as the investigation is complete.

• Brand Name: SMR Shoulder System
• Common Device Name: Reverse Liner 40mm +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: 21770689
• Report Number: 3008021110-2025-00028
• Device Sequence Number: 8235999
• Product Code: KWS
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: 1365.50.815
• Device Lot Number: 23AT24A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: 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: 04/04/2025
• Supplement Report FDA Received Date: 09/29/2026
• 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: Male