MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; MPACT HOODED PE HC LINER Ø32/C

Model Number	01.32.3239HCAT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14-apr-2025.Lot 2409184: (b)(4) items manufactured and released on 29-apr-2024.Expiration date: 14-apr-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.Additional device involved.Batch review performed on 14-apr-2025: cocr 01.25.025 cocr ball head 12/14 ø 32 size xxl +10.5 (k072857) lot 2304109: (b)(4) items manufactured and released on 03-may-2023.Expiration date: 15-apr-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.
Event or Problem Description
At about 11 days after primary, the patient came in reporting recurrent joint luxation.The surgeon revised successfully the medacta implants and implanted stryker mdm cup with cemented stem via a posterior approach.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: MPACT HOODED PE HC LINER Ø32/C
• 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: 21974669
• Report Number: 3005180920-2025-00367
• Device Sequence Number: 17929952
• Product Code: LZO
• UDI-Device Identifier: 07630030811838
• UDI-Public: 07630030811838
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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: 01.32.3239HCAT
• Device Lot Number: 2409184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male