MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; REVERSE LINER 40MM +6MM

Model Number	1365.50.820
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to shoulder dislocation.Previous surgery occurred on (b)(6) 2023 for a reverse total shoulder arthroplasty, with following components: - smr tt baseplate small-r (pn 1375.15.605), - smr glenoid peg tt small-r #medium (pn 1375.14.652), - connector lar +2mm small-r (pn 1374.15.312), - glenosphere dia40mm (pn 1374.09.121, lot 2213444, sterilization (b)(4)), - finned stem short dia25mm (pn 1304.15.025), - 140° reverse humeral body (pn 1352.15.011).- reverse liner +6mm dia40mm (pn 1365.50.820, lot 22at0wc, sterilization (b)(4)).Around 3 years after previous surgery, patient dislocated.Pre-existing connector, glenosphere, reverse humeral body and liner were removed and replaced with a more lateralized and thick assembly consisting of: - connector lat +4mm (pn 1374.15.314), - glenosphere eccentrical dia 40mm (pn 1376.09.041), - 140° reverse humeral body (pn 1352.15.011), - extension for humeral reverse body (pn 1352.15.001), - reverse liner +6mm dia40mm (pn 1365.50.820).Surgery was completed as intended.Patient is male, date of birth (b)(6) 1953.The event occurred in the united states.
Additional Manufacturer Narrative
Preliminary review of manufacturing records did not identify any pre-existing non-conformity that could have contributed to reported issue.The manufacturer will submit a final report as soon as the investigation is completed.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE LINER 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: 25200752
• Report Number: 3008021110-2026-00208
• Device Sequence Number: 15976582
• Product Code: PHX
• UDI-Device Identifier: 08033390102940
• UDI-Public: 8033390102940
• Combination Product (Y/N): N
• PMA/510(K) Number: K142139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/18/2026

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: 1365.50.820
• Device Lot Number: 22AT0WC
• 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: 72 YR
• Patient Sex: Male