MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PRIMA GLENOID SYSTEM; PRIMA TT GLENOID GLENOSPHERE DIA. 40MM

Model Number	1974.09.040
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Shoulder revision surgery due to instability performed on (b)(6) 2025.Previous surgery took place on (b)(6) 2025.The following components were removed: smr reverse liner +6mm d.40mm (part code: 1365.50.820, lot number: 22at16b, sterilization: 2200271).Prima glenosphere d.40 mm (part code: 1974.09.040, lot number: 2433271, sterilization: 2500004).Connector w.Screw low lat.5mm (part code: 1974.15.300, lot number: 2320196, sterilization: 2400132).According to the information received, the initial surgery was performed on (b)(6) 2025, for a fracture.The second revision on (b)(6) 2025, was a planned revision to finish the intended corrections from the first implant.The surgery on (b)(6) 2025 was due to the patient dislocation because the previous revision did not fully stabilize the joint.The patient is a male, date of birth on (b)(6) 1945.The event happened in the united states.
Additional Manufacturer Narrative
Checking the manufacturing and sterilization charts of the components involved in this event, no pre-existing anomaly, that could have contributed to the event, was discovered in the items belonging to the same part codes and lot numbers as the devices removed in the revision surgery hereby reported.The manufacturer will submit a final mdr as soon as the investigation is complete.
Event or Problem Description
Shoulder revision surgery due to instability performed on (b)(6), 2025.Previous surgery took place on (b)(6), 2025.The following components were removed: - smr reverse liner +6mm d.40mm (part code 1365.50.820, lot number 22at16b, sterilization 2200271) - prima glenosphere d.40 mm (part code 1974.09.040, lot number 2433271, sterilization 2500004) - connector w.Screw low lat.5mm (part code 1974.15.300, lot number 2320196, sterilization 2400132) according to the information received, the initial surgery was performed on (b)(6), 2025, for a fracture.The first revision on (b)(6), 2025, was a planned revision to finish the intended corrections from the first implant.The surgery on (b)(6),2025 was due to the patient dislocation because the previous revision did not fully stabilize the joint.The patient is a male, date of birth (b)(6), 1945.The event happened in the united states.
Additional Manufacturer Narrative
Checking the manufacturing and sterilization charts of the components involved in this event, no pre-existing anomaly, that could have contributed to the event, was discovered in the items belonging to the same part codes and lot numbers as the devices removed in the revision surgery hereby reported.From follow-up communication with complaint source no further information regarding the case have been retrieved.Explanted components have been discarded, therefore they are not available for analysis.No x-rays nor pictures of explanted components were provided either.Hence, taking into account that: - dhrs review did not highlight any anomaly on involved lot; - no further events have been reported for involved lots; - explanted components have been discarded and x-rays or pictures have not been provided, therefore no more in-depth investigation can be performed; the manufacturer has no evidence to consider the event as product related.According to the available pms data, the revision rate of prima glenosphere, belonging to the family product codes 1974.09.Xxx and 1976.09.Xxx due to instability is around 0.04%.Based on the investigation performed, no corrective action is required for this specific case.The manufacturer will continue monitoring the market to promptly detect any further similar issue.

• Brand Name: PRIMA GLENOID SYSTEM
• Common Device Name: PRIMA TT GLENOID GLENOSPHERE DIA. 40MM
• 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: 23484043
• Report Number: 3008021110-2025-00138
• Device Sequence Number: 10558621
• Product Code: PHX
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222427
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2026

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?: No
• Device Model Number: 1974.09.040
• Device Lot Number: 2433271
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: 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: 11/06/2025
• Supplement Report FDA Received Date: 07/03/2026
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male