MAUDE Adverse Event Report: Medacta International SA Shoulder System; Humeral reverse HC liner Ø36/+0mm

Model Number	04.01.0119
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the patient had primary shoulder surgery.On (b)(6) 2022, the patient came in reporting pain due to a failed rotator cuff, and the cause of the failed rotator cuff is unknown.The surgeon converted the patient to a reverse shoulder and implanted a competitor glenoid component.The surgery was completed successfully.Presently, on (b)(6) 2026, the patient came in presenting pain due to joint luxation.There was no indication of trauma or fall.During the revision, the metaphysis screw was found loose.The surgeon revised the +9mm/0° metaphysis to a same size metaphysis and revised the d 36/+0 reverse liner to a d 36/+6 constrained liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Clinical evaluation approximately 4 years and 7 months after conversion to reverse shoulder arthroplasty, the patient developed a non-traumatic shoulder dislocation associated with pain and poor range of motion, requiring revision surgery.The available imaging consists of a single radiographic projection, which does not allow reliable confirmation of the dislocation or adequate assessment of prosthetic component positioning.Apparent proximal humeral bone resorption is visible, although this finding may be projection related.During revision, the humeral metaphysis was found loose relative to the stem, with the fixation screw reportedly intact but not engaged with the humeral stem.This finding raises the possibility of inadequate fixation at the metaphysis-stem junction; however, it cannot be determined whether this condition contributed to the dislocation or represented an independent finding.An assembly- or surgery-related mechanism, such as incomplete screw engagement or inadequate tightening during the 2022 procedure, is plausible but unconfirmed.No screw fracture or evidence of a manufacturing or design defect has been demonstrated.With the information available, the definitive root cause of the adverse event cannot be determined.Batch review performed on 2 september 2026 reverse shoulder system 04.01.0119 humeral reverse hc liner d 36/+0mm lot 2100432: (b)(4) items manufactured and released on 06-apr-2021.Expiration date: 21-mar-2026.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0111 humeral reverse metaphysis +9mm/0° (k170452) lot 2012556: (b)(4) items manufactured and released on 28-apr-2021.Expiration date: 13-apr-2026.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Root cause: based on the information available, no definitive root cause can be established.The loose metaphysis with an intact but non-engaged fixation screw may be consistent with incomplete engagement or inadequate tightening during the previous surgery, although this cannot be confirmed.The document review does not indicate any potential manufacturing related cause.

• Brand Name: Shoulder System
• Common Device Name: Humeral reverse HC liner Ø36/+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: 50692286
• Report Number: 3005180920-2026-00939
• Device Sequence Number: 9685010
• Product Code: PHX
• UDI-Device Identifier: 07630040706261
• UDI-Public: 07630040706261
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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 Expiration Date: 03/21/2026
• Device Model Number: 04.01.0119
• Device Lot Number: 2100432
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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: Female
• Patient Race: White