MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; OFFSET 4MM PE HC LINER Ø36/E

Model Number	01.32.3644HC4
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 may 2026 revised stem in the 1st revision surgery: stem: quadra-p 01.12.185 quadra-p collared lat.Size 5 (k192827) lot 2338416: (b)(4) items manufactured and released on 12-dec-2023.Expiration date: 26-nov-2028.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.Revised head and liner in the 2nd revision surgery: ball heads: mectacer 01.29.209 mectacer head biolox delta dia.36 12/14-m (k112115) lot 2521396: (b)(4) items manufactured and released on 08-sep-2025.Expiration date: 19-aug-2030.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.Liner: mpact 01.32.3644hc4 offset 4mm pe hc liner d 36/e (k183582) lot 2431850: (b)(4) items manufactured and released on 24-feb-2025.Expiration date: 05-feb-2030.No anomalies found related to the problem.To date, 15 items of the same lot have been sold with no similar reported event during the period of review.Root cause: dislocation is possible literature described adverse event after primary hip arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event and the investigation does not indicate any potential manufacturing related issue or systemic deficiency.
Event or Problem Description
This was the second revision for patient.The primary surgery was performed on (b)(6) 2024.The first revision surgery was performed on (b)(6) 2025; the stem was revised, but the reason is unknown.No other info is available regarding this revision surgery.A second revision surgery was performed on (b)(6) 2026 due to dislocation of the head from the liner.All components revised with double mobility competitor`s component.The reason for revision of the femoral stem is unknown.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: OFFSET 4MM PE HC LINER Ø36/E
• 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: 25230409
• Report Number: 3005180920-2026-00435
• Device Sequence Number: 18688039
• Product Code: LPH
• UDI-Device Identifier: 07630040731058
• UDI-Public: 07630040731058
• Combination Product (Y/N): N
• PMA/510(K) Number: K183582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/20/2026

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: 01.32.3644HC4
• Device Lot Number: 2431850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2025
• 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: 71 YR
• Patient Sex: Male