MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE HC LINER Ø39/+3MM

Model Number	04.01.0123
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 june 2026 reverse shoulder system 04.01.0123 humeral reverse hc liner d 39/+3mm (k170452) lot 2112133: 90 items manufactured and released on 11-oct-2021.Expiration date: 27-sep-2026.No anomalies found related to the problem.To date, 88 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 2115876: 38 items manufactured and released on 08-mar-2022.Expiration date: 27-feb-2027.No anomalies found related to the problem.To date, 32 items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2110702: 377 items manufactured and released on 22-feb-2022.Expiration date: 01-feb-2027.No anomalies found related to the problem.To date, 377 items of the same lot have been sold with no similar reported event during the period of review.Root cause:based on the available information, the reported instability may be related to soft tissue laxity, which is a known possible complication following tsa, as soft tissues may stretch over time and provide insufficient stability.No evidence of device malfunction was identified, and the device history record review did not reveal any discrepancies.
Event or Problem Description
The patient had primary left shoulder surgery on (b)(6) 2022.On (b)(6) 2022, the patient came in reporting pain due to a dislocation of the liner from the glenosphere that was sustained while the patient was sleeping.The surgeon revised the glenosphere and liner and the surgery was completed successfully (mdr 2022-00683).Presently, on (b)(6) 2026, the patient came in presenting instability and the cause is unknown.There was no indication of trauma.The surgeon revised the glenosphere from 39xd 24.5 to 42xd 24.5, the metaphysis +0mm/0° to a same size metaphysis and the humeral reverse hc liner d 39/+3mm to a hum.Rev.Constrained e-cross liner d 42/+3.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE HC LINER Ø39/+3MM
• 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: 25763465
• Report Number: 3005180920-2026-00691
• Device Sequence Number: 10540892
• Product Code: PHX
• UDI-Device Identifier: 07630040706308
• UDI-Public: 07630040706308
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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: 09/27/2026
• Device Model Number: 04.01.0123
• Device Lot Number: 2112133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• 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: Male
• Patient Race: White