MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; HUMERAL EXTENSION +9MM

Model Number	1352.15.001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Loose body in joint (4926)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 due to disassembly of components in shoulder prosthesis.The extension for humeral body (part number 1352.15.001, lot unknown) disassociated from the humeral body, therefore surgeon replaced it with a new spacer (part number 1352.15.001) and renewed the retentive liner +6mm (part number 1361.50.820) for compatibility reasons, even though no issue was reported on the liner.Surgery has completed as intended.Previous surgery date is unknown, as well as all the previously implanted components.Patient is male, date of birth (b)(6) 1951.The event occurred in the united states.
Additional Manufacturer Narrative
Parts have been discarded therefore cannot be returned to manufacturer for identification and investigation.No review of manufacturing records for complained part is therefore possible.The manufacturer will provide a final report as soon as the investigation is completed.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL EXTENSION +9MM
• 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: 23944385
• Report Number: 3008021110-2026-00005
• Device Sequence Number: 7875473
• Product Code: PHX
• UDI-Device Identifier: 08033390272513
• UDI-Public: 8033390272513
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 01/02/2026

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: 1352.15.001
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2026
• 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 Sex: Unknown