MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE HC LINER Ø42/+0MM

Model Number	04.01.0125
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year 1 month after the primary, the patient came in due to pain due to a fractured acromium and it is unknown how this occured.During surgery, it was determined that the liner had also dislocated from the glenosphere.The surgeon upsized the poly to prevent future dislocation with plans for a future surgery to correct the acromium.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 11 december 2025 reverse shoulder system 04.01.0125 humeral reverse hc liner d 42/+0mm (k170452) lot: 2303291: (b)(4) items manufactured and released on 03-july-2023.Expiration date: 2028-06-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Reverse shoulder system 04.01.0174 glenosphere - d 42x27 (k170452) lot: 1908175: (b)(4) items manufactured and released on 15-jan-2020.Expiration date: 2025-01-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation: revision about 1 year 1 month after the primary due to a fractured acromium and it is unknown how this occured.Additionally, during surgery, it was found that the articulation was not stable.The fracture may have happened due to lateralization of the prosthesis as no traumatic event has been reported but we have no sufficient data to exclude it.Additionally, from the radiographic image the bone quality seems low and this can be also the cause of the fracture of the acromion.There is no reason to suspect a malfunctioning device.Root cause: joint luxation.Although a precise root cause cannot be established, these events are generally related to insufficient re-establishment of soft tissue tension after surgery.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 manufacturing-related issue.Bone fracture: fracture of the acromion is an established possible complication of reverse shoulder arthroplasty, and it can be related to many factors, both patient-specific and intra-operative.Although a certain root cause cannot be identified, the overall analysis did not reveal any anomalies and there is no indication that any potential issue with the device may have caused or contributed to the event.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE HC LINER Ø42/+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: 23836923
• Report Number: 3005180920-2025-01261
• Device Sequence Number: 5081110
• Product Code: PHX
• UDI-Device Identifier: 07630040706322
• UDI-Public: 07630040706322
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 12/18/2025

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: 04.01.0125
• Device Lot Number: 2303291
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2023
• 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: 63 YR
• Patient Sex: Male
• Patient Race: White