MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MSS - HUMERAL REVERSE LINERS; HUM. REV. CONSTRAINED HCPE LINER Ø39/+6

Model Number	04.01.0450
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a primary reverse shoulder arthroplasty was performed for a fracture that had not healed (failure of fixation).On (b)(6) 2026 there was a trauma related dislocation on (b)(6) 2026, a first revision surgery was performed due to recurrent instability/dislocations.The surgeon revised the liner and upsized the glenosphere from 36 mm to 39 mm, and changed the metaphysis to a reverse metaphysis +9 mm/+20°.On (b)(6) 2026 there was another trauma related dislocation on (b)(6) 2026, a reduction was performed under anesthesia following additional dislocations, on (b)(6) 2026, a second revision surgery was performed due to persistent instability.The surgeon revised the liner to a constrained hcpe liner d 39/+6 and the metaphysis to a humeral reverse metaphysis +9 mm/0°.On (b)(6) 2026, the surgeon reported that the patient had dislocated again.Concerns were raised regarding possible neurological impairment related to the patient`s previous brachial plexus injury, potentially causing issues with function, muscle tone, and strength.They will not proceed with a revision for the moment and will monitor the patient due to her severe neurological condition.They are also seeking a second opinion to assess whether any further procedure is required.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2025 reverse shoulder system 04.01.0450 hum.Rev.Constrained hcpe liner d 39/+6 (k250338) lot 2528162: 27 items manufactured and released on 22-dec-2025.Expiration date: 02-dec-2030.No anomalies found related to the problem.To date, 4 items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0208 lat.Glenosphere 39xd 24.5 (k193175) lot 2405693: (b)(4) items manufactured and released on 13-jun-2024.Expiration date: 27-may-2029.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.Root cause:dislocation is possible literature described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event and the investigation does not indicate any potential manufacturing related issue or systemic deficiency.

• Brand Name: MSS - HUMERAL REVERSE LINERS
• Common Device Name: HUM. REV. CONSTRAINED HCPE LINER Ø39/+6
• 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: 25442520
• Report Number: 3005180920-2026-00536
• Device Sequence Number: 14888100
• Product Code: PHX
• UDI-Device Identifier: 07630542750441
• UDI-Public: 07630542750441
• Combination Product (Y/N): N
• PMA/510(K) Number: K250338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/09/2026

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: 04.01.0450
• Device Lot Number: 2528162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2025
• 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: Other
• Patient Sex: Female
• Patient Race: White