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

Model Number	9019.74.140
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a review of the device history records (dhr) of glenosphere extractor instrument (product code: 9019.74.140) could not be performed, as the lot number of the instrument is unknown.Consequently, traceability to manufacturing and quality records was not possible.According to the complaint source, the instrument was checked a few days after the reported event and was found to be functioning normally.They stated that the malfunctioning was due to an intra-operative error.The was completed without any problem and no patient harm.The device was not returned for further investigation into limacorporate; therefore, inspection was not possible.In conclusion: based on the limited data available, a comprehensive analysis of the complaint cannot be carried out.The absence of the product lot number prevents a review of the relevant production records, and without access to the instrument involved, it is not possible to further investigate.Should any additional information arise, the complaint will be reassessed accordingly.Pms data: according to our pms this is the only similar complaint received for glenosphere extractor instrument (product code: 9019.74.140) not engaging the glenosphere.This is an initial-final mdr report.
Event or Problem Description
During surgery on (b)(6) 2025 the thread of the glenosphere extractor instrument (product code: 9019.74.140; lot number: unknown) did not engage with the glenosphere (product code: 1974.54.440; lot number: 2424139) and therefore could not be used to extract the glenosphere.The surgeon removed the glenosphere by using a hook to tap it out and then implanted a new glenosphere to complete the procedure.The surgical time was prolonged by approximately 15 minutes due to this issue.Event occurred in switzerland.

• Brand Name: PRIMA TT GLENOID
• Common Device Name: PRIMA TT GLENOID - GLENOSPHERE/BASEPLATE EXTRACTOR
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24222954
• Report Number: 3008021110-2026-00078
• Device Sequence Number: 8197486
• Product Code: PHX
• UDI-Device Identifier: 08033390241069
• UDI-Public: 08033390241069
• Combination Product (Y/N): N
• 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): 01/30/2026

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: 9019.74.140
• Device Catalogue Number: 9019.74.140
• Device Lot Number: UKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 01/30/2026
• 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