MAUDE Adverse Event Report: Limacorporate S.p.A. SMR Shoulder System; Reverse liner Dia.40mm, +6mm

Model Number	1365.54.820
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing chart of the lot number 23at3z4, no pre-existing anomaly has been found out in the items manufactured with the same lot number.We will submit a final report as soon as the investigation is complete.
Event or Problem Description
Shoulder revision surgery performed on (b)(6) 2025, due to dislocation.Previous surgery took place on (b)(6) 2024 and during this surgery the following component were implanted: smr finned stem short d.18 (part code 1304.15.018, lot number 2424861, sterilization (b)(4)).Smr reverse humeral body (part code 1352.15.010, lot number 2424902, sterilization (b)(4)).Reverse liner +6 mm d.40 mm (part code 1365.54.820, lot number 23at3z4, sterilization (b)(4)).Connector w.Screw high lat.9mm (part code 1974.15.304, lot number 2417922, sterilization (b)(4)).Baseplate d.25mm full wedge10° (part code 1975.14.510, lot number 2413702, sterilization (b)(4)).Glenosph.Ecc.D.40mm ecc.4mm (part code 1976.09.040, lot number 2410437, sterilization (b)(4)).During the revision surgery the reverse liner +6 mm d.40 mm previously implanted was removed and replaced by the following new components: extension for humeral reverse body (part code 1352.15.001, lot number 2416707, sterilization (b)(4)).Smr reverse liner retentive +3mm dia=40mm (part code 1365.54.816, lot number 23at3v4, sterilization (b)(4)).The patient is a male, date of birth (b)(6) 1944.The event happened in the united states.

• Brand Name: SMR Shoulder System
• Common Device Name: Reverse liner Dia.40mm, +6mm
• 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: 21415269
• Report Number: 3008021110-2025-00008
• Device Sequence Number: 18086507
• Product Code: PHX
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: 1365.54.820
• Device Lot Number: 23AT3Z4
• 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: 02/19/2025
• Supplement Report FDA Received Date: 09/28/2026
• 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