MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE HC LINER Ø32/+0MM

Model Number	04.01.0116
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 march 2026.Reverse shoulder system 04.01.0116 humeral reverse hc liner d 32/+0mm lot 2402701 (k170452): 90 items manufactured and released on 28 may 2024.Expiration date: 2029-may-14.No anomalies found related to the problem.To date, 54 items of the same lot have been sold with no similar reported events during the period of review.Reverse shoulder system 04.01.0206 lat.Glenosphere 32xd 24.5 lot 2431813 (k193175): 20 items manufactured and released on 26 mar 2025.Expiration date: 2030-mar-12.No anomalies found related to the problem.To date, 17 items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation based on the information available, the revision surgery was performed approximately eight months after the primary procedure due to instability, with the cause reported as unknown.During the revision, the surgeon replaced all medacta components with competitor implants.No additional details regarding the clinical decision-making or intraoperative findings were provided.A review of the postoperative radiograph shows poor bone quality and a suboptimal position of both the baseplate and the glenosphere, which appear positioned too superiorly.At this stage, it is not possible to determine whether this positioning is the result of postoperative migration or a surgical choice during the primary procedure.In the latter case, no explanation for such positioning was documented.Given these radiographic findings, it is highly likely that a portion of the humeral stem may have impinged on the glenoid cavity, potentially contributing to baseplate movement over time.While the complaint reports “instability,” the imaging instead indicates that the non optimal placement of the glenosphere and baseplate may have played a significant role in the failure of the construct.In the absence of further clinical details or intraoperative insights, no definitive root cause can be established.Root cause: based on the information available no definitive root cause can be established, however, the non-optimal superior positioning of the baseplate and glenosphere may have contributed to instability and subsequent construct failure over time.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
Revision surgery due to instability about 8 months after primary surgery and the cause is unknown.The surgeon revised all medacta implants (metaphysis, liner, diaphysis, glenosphere, and baseplate) to competitor implants.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE HC LINER Ø32/+0MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24741263
• Report Number: 3005180920-2026-00278
• Device Sequence Number: 8695047
• Product Code: PHX
• UDI-Device Identifier: 07630040706230
• UDI-Public: 07630040706230
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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
• Operator of Device: Health Professional
• Device Model Number: 04.01.0116
• Device Lot Number: 2402701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2024
• 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