MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; FACE CHANG 10° PE HC LINER Ø36/F

Model Number	01.32.3648HC10A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent primary right hip surgery on (b)(6) 2024.On (b)(6) 2024, the patient presented with pain due to a dislocation of the femoral head from the liner.The surgeon revised the head and liner (mdr: (b)(4).On (b)(6) 2025, the patient presented with pain due to a dislocation of the femoral head from the liner.The surgeon revised the medacta head and stem to a competitor head and stem and upsized the medacta liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 22 dec 2025.Liner: mpact 01.32.3648hc10a face chang 10°; pe hc liner d 36/f (k1835829 lot: 2401183: (b)(4) items manufactured and released on 05 february 2024.Expiration date: 21 jan 2029.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.Ball heads: mectacer 01.29.211 biolox delta ceramic ball head 12/14 d 36 size xl +8 (k112115) lot: 2311918: (b)(4) items manufactured and released on 14 june 2023.Expiration date: 29 may 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.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 ACETABULAR SYSTEM
• Common Device Name: FACE CHANG 10° PE HC LINER Ø36/F
• 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: 23864303
• Report Number: 3005180920-2025-01311
• Device Sequence Number: 15954205
• Product Code: LPH
• UDI-Device Identifier: 07630040731072
• UDI-Public: 07630040731072
• 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: 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: 01.32.3648HC10A
• Device Lot Number: 2401183
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2024
• 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