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

Model Number	01.32.3644HC10A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2021.On (b)(6) 2021, the patient came in reporting pain due to a dislocation of the head from the liner.The cause of the dislocation is unknown.The surgeon revised the head and liner and the surgery was completed successfully.Presently, on (b)(6) 2025, the patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.The surgeon revised the medacta cup and liner to competitor components and revised the medacta head with a medacta head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 18 march 2025: lot 2009675: (b)(4) items manufactured and released on 01-dec-2020.Expiration date: 2025-11-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with four similar reported events during the period of review.Additional implant involved; batch review performed on 18 march 2025: ball heads: mectacer 01.29.232h head biolox option ø 36 (k131518) lot 2104459: (b)(4) items manufactured and released on 02-sep-2021.Expiration date: 2026-07-28.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.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-CHANGING 10° PE HC LINER Ø36/E
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21642678
• Report Number: 3005180920-2025-00228
• Device Sequence Number: 7554308
• Product Code: LPH
• UDI-Device Identifier: 07630040731034
• UDI-Public: 07630040731034
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K183582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2025

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: 11/17/2025
• Device Model Number: 01.32.3644HC10A
• Device Lot Number: 2009675
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2020
• 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: 73 YR
• Patient Sex: Female
• Patient Race: White