MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SYSTEM; SMR SYSTEM - GLENOSPHERE DIA. 36 MM SMALL-R

Model Number	1374.09.105
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a surgery on (b)(6) 2025, the surgeon implanted the metal-back glenoid small-r (product code: 1375.20.005 - lot: 2513700 - ster: (b)(4) and fixed it with two screws, as planned.After that, the 36 glenosphere (product code: 1374.09.105 - lot: 2514000 - ster: (b)(4) was connected to the connector from the same package and attached to the impactor, which was fully secured.The assembly was placed in situ using a mallet.However, the glenosphere could not be fixed.Consequently, the surgeon removed it, disconnected the connector from the glenosphere, and fixed it to the metal-back.A further attempt to place the glenosphere was made, but again it was not possible.The screws, the metal-back, and the connector were removed together.The connector was then detached from the metal-back, and the implantation process was restarted, yet the same issue occurred.As a result, the surgeon removed the components and changed to a metal-back small and the suitable glenosphere 36 and connector.There was sufficient bone stock at the glenoid, allowing the implants to be placed in situ without any further issues.The physician who performed the surgery is an smr-experienced surgeon.There was a delay of 15 minutes on the surgery.Event occurred in switzerland.
Additional Manufacturer Narrative
The check of dhrs of the involved lot lumber 2514000 did not highlight any pre-existing anomalies on the pieces manufactured.This is the first and only complaint received about on lot number: 2514000.A final report will be submitted at the conclusion of the investigation.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR SYSTEM - GLENOSPHERE DIA. 36 MM SMALL-R
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 23523309
• Report Number: 3008021110-2025-00147
• Device Sequence Number: 9742143
• Product Code: PHX
• UDI-Device Identifier: 08033390272216
• UDI-Public: 08033390272216
• 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): 11/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1374.09.105
• Device Catalogue Number: 1374.09.105
• Device Lot Number: 2514000
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/11/2025
• 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: Other
• Patient Sex: Unknown