MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 15

Model Number	01.32.6515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had pain located in the pelvic region and the cause is unknown.The patient believed the pain was due to screw placement during primary surgery.The surgeon removed the 15mm and 20mm screws implanted during the primary.The surgeon also revised the 36mm biolox head to a 28mm biolox head, revised the flat d 36 liner to a d 28 double mobility liner, and implanted a dm converter and biolox option sleeve.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch reviews performed on 22 december 2025: screws: mpact 01.32.6515 cancellous bone screw flat head d 6,5 l (k103721) lot 2002399:(b)(4) items manufactured and released on 29-may-2020.Expiration date: 2025-may-14.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 01.32.6520 cancellous bone screw flat head d 6,5 l 20 (k103721) lot 2002400: (b)(4) items manufactured and released on 04-jun-2020.Expiration date: 2025-may-18.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.3 devices of the same lot involved in this case.Root cause: although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event.The investigation results do not indicate any potential manufacturing issue.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 15
• 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: 23876933
• Report Number: 3005180920-2025-01329
• Device Sequence Number: 9464598
• Product Code: LPH
• UDI-Device Identifier: 07630030812361
• UDI-Public: 07630030812361
• Combination Product (Y/N): N
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 12/23/2025

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 Expiration Date: 05/14/2025
• Device Model Number: 01.32.6515
• Device Lot Number: 2002399
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2020
• 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: 47 YR
• Patient Sex: Female
• Patient Race: White