MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; HIP ACETABULAR CUP

Model Number	01.32.3644HC10A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 sept 2024.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, 31 items of the same lot have been sold with other 3 similar reported events during the period of review.
Event or Problem Description
At 4 months from the primary, the patient came in reporting pain, due to a dislocation of the competitor head from the medacta liner, and the cause of the dislocation is unknown.The surgeon revised medacta flat liner with a medacta face changing liner and the surgery was completed successfully.A direct anterior approach was utilized in the primary surgery.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: HIP ACETABULAR CUP
• 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: 20359324
• Report Number: 3005180920-2024-00782
• Device Sequence Number: 8127223
• Product Code: LPH
• UDI-Device Identifier: 07630040731034
• UDI-Public: 07630040731034
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

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: 09/04/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• 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