MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 25

Model Number	01.32.6525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-dec-2025.Screws: mpact 01.32.6525 cancellous bone screw, flat head d 6,5 l 25 (k103721) lot.2218814: (b)(4) items manufactured and released on 07-sep-2022 expiration date: 2027-08-22.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.Screws: mpact 01.32.6525 cancellous bone screw, flat head d 6,5 l 25 (k103721) lot.2212605: (b)(4) items manufactured and released on 23-jun-2022 expiration date: 2027-06-02.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.Clinical evaluation performed by clinical affairs department.Almost 3 years after primary cementless tha on a lady patient, a screw protruding beyond the medial acetabular wall gives irritation and needs to be removed.The cause of irritation is exclusively the wrong position of the screw at index surgery (reasons unknown) and should not be ascribed to a malfunctioning or defective device.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.
Event or Problem Description
At about 2 years and 9 months from primary the patient reported pain, perforation of the pelvic wall from one of the screw was identified.The screw was irritating the psoas muscle and nerve.It is unknown which of the two screws was protruding.Surgeon revised the screws, head and liner.Surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 25
• 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: 23862959
• Report Number: 3005180920-2025-01284
• Device Sequence Number: 9409564
• Product Code: LPH
• UDI-Device Identifier: 07630030812385
• UDI-Public: 07630030812385
• Combination Product (Y/N): N
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 12/22/2025

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: 01.32.6525
• Device Lot Number: 2218814
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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