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

Model Number	1360.50.820
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary review of manufacturing records 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 shoulder dislocation.Previous surgery occurred on (b)(6) 2025 when original anatomic prosthesis was conversed to a reverse configuration due to rotator cuff failure (previously reported with mfr.3008021110-2026-00073).Patient dislocated and the surgeon decided to perform a revision surgery since they could not reduce the dislocation of the reverse in other way.During revision, the pre-existing smr small/std connector +2mm (pn 1374.15.322, lot 2514593, sterilization (b)(4), glenosphere ø 36mm (pn 1374.09.111,lot 2515422, sterilization 2500135) and smr reverse liner + 6 mm (pn 1360.50.820, lot 23at40j, sterilization 2400057) were removed and replaced with new connector, eccentrical glenosphere dia40mm (pn 1376.09.041) and reverse liner retentive +3mm (pn 1365.50.816).Reverse liner was found dissociated from humeral body during revision.Surgery was completed as intended.Patient is male, date of birth (b)(6) 1951.The event occurred in the united states.

• 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: 25200759
• Report Number: 3008021110-2026-00211
• Device Sequence Number: 10096421
• 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
• 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): 05/18/2026

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: 23AT40J
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2026
• 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: 74 YR
• Patient Sex: Male