MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; REVERSE LINER 40MM STANDARD

Model Number	1365.50.810
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have been discarded therefore cannot be returned to manufacturer for analysis.Review of production records for complained component has been performed and did not highlight any anomaly.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery occurred on (b)(6) 2026 due to implant dislocation.Previous surgery was performed on (b)(6) 2025 and following components were implanted: - finned stem dia 14 mm l.80 mm (pn 1304.15.140, lot.2501562, ster.(b)(4)).- humeral body reverse (pn 1352.15.010, lot.2524608, ster.(b)(4)).- reverse liner std 40mm (pn 1365.50.810, lot.24at31q, ster.(b)(4)).- eccentrical glenosphere 40mm (pn 1376.09.041, lot.2517012, ster.(b)(4)).- connector with screw small r (pn 1374.15.305, lot.2525209, ster.(b)(4)).- metal back glenoid small-r (pn 1375.21.005, lot.2523946, ster.(b)(4)).- bone screw dia 6,5 mm l20 mm (pn 8420.15.010, lot.2523113, ster.(b)(4)).Patient dislocated and, as a consequence, during revision the surgeon removed above mentioned reverse liner std 40mm and replace it with a reverse retentive standard 40mm (pn 1365.50.811).Surgery was completed as intended.Patient is female, date of birth (b)(6) 1950.Event occurred in united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: REVERSE LINER 40MM STANDARD
• 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: 24638408
• Report Number: 3008021110-2026-00153
• Device Sequence Number: 13201738
• Product Code: PHX
• UDI-Device Identifier: 08033390102919
• UDI-Public: 8033390102919
• Combination Product (Y/N): N
• PMA/510(K) Number: K142139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 03/17/2026

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: 1365.50.810
• Device Lot Number: 24AT31Q
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2026
• 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 Age: 76 YR
• Patient Sex: Female