MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PRIMA TT GLENOID; PRIMA TT GLENOID - GLENOSPHERE PUSHER

Model Number	9019.74.152
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint source reported that during a shoulder surgery performed on (b)(6) 2026, it was not possible to insert the glenosphere into the glenosphere pusher (product code: 9019.74.152 - lot nr: unknown) designed for this purpose.This malfunction added approximately 30 minutes to the procedure.Event occurred in france.
Additional Manufacturer Narrative
The review of device history records is not possible to be performed since the lot number of the instrument involved is unknown.A final report will be submitted after the investigation is completed.

• Brand Name: PRIMA TT GLENOID
• Common Device Name: PRIMA TT GLENOID - GLENOSPHERE PUSHER
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24995512
• Report Number: 3008021110-2026-00199
• Device Sequence Number: 18400544
• Product Code: HSD
• UDI-Device Identifier: 08033390272698
• UDI-Public: 08033390272698
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• 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): 04/24/2026

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: 9019.74.152
• Device Catalogue Number: 9019.74.152
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/27/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown