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

Model Number	1360.50.810
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
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 submit a final report as soon as the investigation is completed.
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 (b)(6) 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; and smr reverse liner +6mm pn 1360.50.820).(b)(6) 2026: revision surgery for shoulder dislocation (reported with reference mfr.3008021110-2026-00195) 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, lot 2539123, sterilization 2600021), 140° humeral body finned reverse (pn 1352.15.051, lot 2541489, sterilization 2600021) and smr reverse liner standard (pn 1360.50.810, lot 25at2x3, sterilization 2500203).(b)(6) 2026: revision surgery for shoulder dislocation (hereby reported) 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.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE LINERS 36MM (UHMWPE) 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: 25067091
• Report Number: 3008021110-2026-00201
• Device Sequence Number: 10357580
• Product Code: PHX
• UDI-Device Identifier: 08033390273589
• UDI-Public: 8033390273589
• 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: 1360.50.810
• Device Lot Number: 25AT2X3
• 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