MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT EXTENSION; CANCELLOUS BONE SCREW Ø 6,5 L40

Model Number	01.43.0040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient initially underwent primary surgery with competitor products.On (b)(6) 2026, a revision was performed using a medacta mpact cup and liner.On (b)(6) 2026, the patient presented with pain, which was attributed to excessively long screws from the primary surgery protruding into surrounding soft tissue.The surgeon revised the screws, replacing l30, l35, and l40 with shorter l15 and two l20 screws, and also exchanged the liner with the same size.The procedure was completed successfully.The reported pain was caused by soft tissue irritation due to screw protrusion.No x-rays are available, although they have been requested.
Additional Manufacturer Narrative
Batch reviews performed on 23 march 2026: screws: mpact 01.43.0040 cancellous bone screw d 6,5 l40 (k200391) lot 2312909: 80 items manufactured and released on 12-jul-2023.Expiration date: 2028-06-27.No anomalies found related to the problem.To date, 24 items of the same lot have been sold with no similar reported event during the period of review.Screws: mpact 01.43.0035 cancellous bone screw d 6,5 l35 (k200391) lot 2319087: 80 items manufactured and released on 13-sep-2023.Expiration date: 2028-aug-22.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.Screws: mpact 01.43.0030 cancellous bone screw d 6,5 l30 (k200391) lot 2519084: 80 items manufactured and released on 29-sep-2025.Expiration date: 2030-sep-11.No anomalies found related to the problem.To date, 40 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, while 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 potential manufacturing related issue.

• Brand Name: MPACT EXTENSION
• Common Device Name: CANCELLOUS BONE SCREW Ø 6,5 L40
• 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: 24762676
• Report Number: 3005180920-2026-00296
• Device Sequence Number: 16021472
• Product Code: MEH
• UDI-Device Identifier: 07630971257504
• UDI-Public: 07630971257504
• Combination Product (Y/N): N
• PMA/510(K) Number: K200391
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/02/2026

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: 01.43.0040
• Device Lot Number: 2312909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2023
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 42 KG