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

Model Number	9019.74.300
Medical Device Problem Codes	Mechanical Problem (1384); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Checking the manufacturing charts of the involved lot # 22aq2me, no pre-existing anomaly was found.This is the first and only complaint received on this lot #.We will submit a final report as soon as the investigation is complete.
Event or Problem Description
During revision shoulder surgery performed on (b)(6) 2023, the surgeon attempted to remove a adapter component with the instrument connector extractor, commercial code 9019.74.300 - lot #22aq2me.The instrument would not separate morse taper of the adapter from baseplate.Fix was to replace liner with constrained liner.This resulted in a surgery delay of 20 minutes.However, no consequences have been experienced for the patient.Patient - male.Birth date - (b)(6) 1944.Event happened in u.S.
Additional Manufacturer Narrative
Investigation checking the manufacturing charts of the involved lot number 22aq2me, no pre-existing anomaly was found, that could have contributed to the event.This is the first and only complaint received regarding this lot number.In late 2023 the manufacturer received the instrument involved in the complaint and performed the following test: the adaptor has been connected to a baseplate by hammering it and then the connection was completed by tightening a safety screw in order to replicate the surgical steps.Following these steps, it was impossible to separate the connector from the baseplate, so the malfunction was confirmed.Moreover, a dimensional check was conducted on other pieces belonging to the same lot number as the component involved in the complaint and on some pieces belonging to different lot numbers, leading to find some dimensions slightly out of tolerances in the instruments belonging to the lot 22aq2me.In the light of these results, in april 2024 the manufacturer decided to perform a corrective and preventive action, with the aim of improving the instrument design, increasing the mechanical strength of the retentive sleeve and introducing the 100% check of dimension of the looking teeth.These improvements were implemented in the new version of the instrument, with part code 9019.74.301, which is the only one currently used in the market.Pms data according to the relevant pms, the manufacturer received one complaint (hereby reported) and one feedback (that occurred out of the operative room, without involving any patient) about the connector extractor with part code 9019.74.300.As described above, a capa plan has been already put in place by the company.The corrective action is currently closed.The manufacturer will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.
Event or Problem Description
During revision shoulder surgery performed on (b)(6) 2023, the surgeon attempted to remove an adapter component with the instrument connector extractor (part code 9019.74.300, lot number 22aq2me).The instrument would not separate morse taper of the adapter from baseplate.Fix was to replace liner with constrained liner.This resulted in a surgery delay of 20 minutes.However, no consequences have been experienced for the patient.The patient is a male, date of birth (b)(6) 1944.Event happened in the united states.

• Brand Name: PRIMA TT GLENOID
• Common Device Name: PRIMA TT GLENOID - CONNECTOR EXTRACTOR
• 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: 17002142
• Report Number: 3008021110-2023-00049
• Device Sequence Number: 7150721
• Product Code: PHX
• UDI-Device Identifier: 08033390241083
• UDI-Public: 08033390241083
• 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,Followup
• Report Date (Section B): 07/07/2025

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?: Yes
• Device Model Number: 9019.74.300
• Device Catalogue Number: 9019.74.300
• Device Lot Number: 22AQ2ME
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 07/07/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 78 YR
• Patient Sex: Male