MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; 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	03/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to shoulder dislocation.Previous surgery was performed on (b)(6) 2026 for a reverse total shoulder arthroplasty with following components: monoblock reverse tt baseplate dia25mm regular (pn 1975.14.500) prima tt glenosphere dia40mm (pn 1974.09.040) prima glenosphere connector high lateralization 9mm (pn 1974.15.304) smr finned stem short dia 18mm (pn 1304.15.018) 140° humeral reverse body (pn 1352.15.011) reverse liner std dia40mm (pn 1365.50.810, lot 24at5nw, sterilization (b)(4).After dislocation, the surgeon revised the patient and replaced the pre-existing liner with another one of same type.Surgery was completed as intended.Patient is male, date of birth (b)(6) 1954.The event occurred in the united states.
Additional Manufacturer Narrative
Preliminary review of manufacturing and sterilization records did not highlight any pre-existing non-conformity on involved batch.The manufacturer will submit a final report as soon as the investigation is completed.

• Brand Name: SMR SHOULDER
• 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: 25200758
• Report Number: 3008021110-2026-00209
• Device Sequence Number: 10096420
• 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: 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): 05/18/2026

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: 1365.50.810
• Device Lot Number: 24AT5NW
• 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: 71 YR
• Patient Sex: Male