MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM GLENOID BASEPLATE - Ø27X25

Model Number	04.01.0155
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Post-operative cts show that the baseplate slopes downwards (there may be a fracture of the glenoid but that was not noticeable per-operative), differently from the planning.However, no issue occurred during the surgery regarding nextar technology or the planning.The patient is doing quite well.The surgeon is not planning any revision.
Additional Manufacturer Narrative
Batch review performed on 14 nov 2024: lot 2344016: (b)(4) items manufactured and released on 02-apr-2024.Expiration date: 2029-mar-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Logfile analysis: the analysis of the provided log files did not highlight any issue regarding nextar workflow.Registration was completed successfully and achieved positioning was saved during the reaming step.Saved values of the reaming report: sup.Inclination: 3° retroversion: -3° depth: 0mm these values are very similar to the planed ones.It is not possible to hypothesize the root cause of the reported behavior.My solution planning analysis our analysis of the my shoulder process for this case found no deviations from the standard procedures.Each step has been performed correctly.No root cause can be identified.
Additional Manufacturer Narrative
Follow-up generated by the receipt of the ct scans on (b)(6) 2025.Mysolution planning analysis: our analysis of the myshoulder process for this case found no deviations from the standard procedures.Each step has been performed correctly.No root cause can be identified.Post-operative ct has been compared with the planning: it is noticeable that the preoperative indication was not met, especially regarding the retroversion of the implant.It is not possible to define the root cause of the malpositioning.Conclusions: the overall investigation did not reveal any anomalies related to the planning or nextar technology.The event could be related to anomalous factors unrelated to the device or the technology used intra-operatively, but the information received is not sufficient to determine a certain root cause.
Event or Problem Description
Surgery was performed on (b)(6) 2024.Post-operative cts (taken on (b)(6)2024) show that the baseplate slopes downwards (there may be a fracture of the glenoid but that was not noticeable per-operative), differently from the planning.However, no issue occurred during the surgery regarding nextar technology or the planning.The patient is doing quite well.The surgeon is not planning any revision.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE - Ø27X25
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20832757
• Report Number: 3005180920-2024-01000
• Device Sequence Number: 14418741
• Product Code: PHX
• UDI-Device Identifier: 07630040706421
• UDI-Public: 07630040706421
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.01.0155
• Device Lot Number: 2344016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2024
• 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 Sex: Unknown