MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; REVERSE LINERS 36MM (UHMWPE) +6MM

Model Number	1360.50.820
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to dislocation.Patient clinical history summary is the following: (b)(6) 2025: original surgery with smr humeral components (finned stem dia.19 mm l.80mm pn 1304.15.190; 140° humeral body reverse pn 1352.15.011; extension for humeral reverse body pn 1352.15.001; smr reverse liner +3mm pn 1360.50.815) and djo altivate glenoid components.(b)(6) 2026: revision surgery for humeral stem loosening (previously reported with reference mfr.3008021110-2026-00183) was performed to replace all existing components with new ones (on the humeral side the above mentioned components were replaced with finned stem dia.20 mm l.80mm pn 1304.15.200; 140° humeral body reverse pn 1352.15.011, lot 2535453, sterilization (b)(6); and smr reverse liner +6mm pn 1360.50.820, lot 25at1ab, sterilization (b)(6)).(b)(6) 2026: revision surgery for shoulder dislocation (hereby reported) was performed replacing the above mentioned 140° humeral body reverse and smr reverse liner +6mm with new extension for humeral reverse body (pn 1352.15.001), 140° humeral body finned reverse (pn 1352.15.051) and smr reverse liner standard (pn 1360.50.810).(b)(6) 2026: revision surgery for shoulder dislocation (reported with reference mfr.3008021110-2026-00201) was performed replacing the recently implanted extension for humeral reverse body, 140° humeral body finned reverse and smr reverse liner standard with new components (extension for humeral reverse body pn 1352.15.001, humeral body finned reverse pn 1352.15.050 and smr reverse liner retentive +6mm dia40mm pn 1365.50.821).In all surgeries the djo altivate glenospheres were replaced as well.Patient is male, date of birth (b)(6) 1961.The event occurred in the united states.
Additional Manufacturer Narrative
Review of manufacturing and sterilization records of involved batches did not identify any pre-existing anomaly or non-conformity that could have contributed to reported issue.The manufacturer will provide a final report as soon as the investigation is completed.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE LINERS 36MM (UHMWPE) +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: 25067089
• Report Number: 3008021110-2026-00195
• Device Sequence Number: 18731375
• Product Code: PHX
• UDI-Device Identifier: 08033390273619
• UDI-Public: 8033390273619
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/04/2026

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: 1360.50.820
• Device Lot Number: 25AT1AB
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2026
• 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: 64 YR
• Patient Sex: Male