MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MSS - HUMERAL REVERSE LINERS; HUM. REV. CONSTRAINED E-CROSS LINER Ø32/+6

Model Number	04.01.0510
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 february 2026.Reverse shoulder system 04.01.0510 hum.Rev.Constrained e-cross liner d 32/+6 (k250338) lot 2503936: (b)(4) items manufactured and released on 25-mar-2025.Expiration date: 09-mar-2030.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.Reverse shoulder system 04.01.0206 lat.Glenosphere 32xd 24.5 (k193175) lot 2430417: (b)(4) items manufactured and released on 4-apr-2025.Expiration date: 17-mar-2030.No anomalies found related to the problem.To date, 13 items of the same lot have been sold with one similar reported event during the period of review.Root cause: dislocation is a 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.No previous case has been addressed to a device design or manufacturing related root cause.
Event or Problem Description
On (b)(6) 2025, a shoulder surgery was performed.Approximately (b)(6) months after the primary, the patient presented with pain associated with recurrent dislocation of the glenosphere and liner; the cause is unknown.Previous episodes were managed with closed reduction.The surgeon revised the liner with a constrained liner of the same size to address the dislocations.The surgery was completed successfully.At about (b)(6) month after the first revision surgery, the patient again presented with pain due to multiple dislocations of the liner from the glenosphere.Previous episodes had been managed with closed reduction.The surgeon revised the baseplate and upsized both the liner and the glenosphere to address the dislocations.The procedure was completed successfully.

• Brand Name: MSS - HUMERAL REVERSE LINERS
• Common Device Name: HUM. REV. CONSTRAINED E-CROSS LINER Ø32/+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: 24376302
• Report Number: 3005180920-2026-00095
• Device Sequence Number: 5572685
• Product Code: PHX
• UDI-Device Identifier: 07630542751073
• UDI-Public: 07630542751073
• Combination Product (Y/N): N
• PMA/510(K) Number: K250338
• 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): 02/18/2026

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: 04.01.0510
• Device Lot Number: 2503936
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2025
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: White