MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PRIMA TT GLENOID; PRIMA TT GLENOID - 4X LOCKING CAPS

Model Number	1975.15.594
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Checking the device history records (dhrs) no pre-existing anomalies were detected on the reported lot number 2434865.This is the first complaint received on lot number 2434865.A final report will be submitted after the investigation is completed.
Event or Problem Description
During surgery, two separate packages of locking caps (product code: 1975.15.594, lot: 2434865 - ster: 2500040) were opened, but the caps could not be applied due to failure of the angle-stable lockiag mechanism.That issue prevented proper fixation.The procedure could not be carried out as planned because the angular-stable caps could not be implanted due to the issue on cap closure.This resulted in a delay of approximately 15-20 minutes.The devices have been discarded.

• Brand Name: PRIMA TT GLENOID
• Common Device Name: PRIMA TT GLENOID - 4X LOCKING CAPS
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 23692503
• Report Number: 3008021110-2025-00162
• Device Sequence Number: 13042557
• Product Code: PHX
• UDI-Device Identifier: 08033390239714
• UDI-Public: 08033390239714
• Combination Product (Y/N): N
• PMA/510(K) Number: K222427
• 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): 12/02/2025

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: 1975.15.594
• Device Catalogue Number: 1975.15.594
• Device Lot Number: 2434865
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown