MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E

Model Number	01.32.3644HCT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 27 december 2024.Lot 2337865: (b)(4) items manufactured and released on 02-oct-2023.Expiration date: 2028-09-19.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.Preliminary investigation based on the pictures received from the received photos a crack in the rim of the polyethylene liner can be noted.A suboptimal alignment of the liner into the cup during impaction may have caused the damage reported, or the presence of soft tissue might have prevented the complete insertion or adherence of the liner in the cup.
Event or Problem Description
After the liner was impacted, a protrusion and a crack was found on the surface.Surgery completed successfully using a back-up.About 30-minute delay occurred to remove the liner and implant a new one.Total surgery time 1.5 hour.
Additional Manufacturer Narrative
Visual inspection performed by r&d department: from the received piece, a crack was found in the rim surface; the reason of the event is unknown from the received information, but it is possible that an improper impaction, more inclined respect to the cup/liner axis, has been applied, causing the crack in the liner rim.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: MPACT 01.32.3644HCT FLAT 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: 21206457
• Report Number: 3005180920-2024-01181
• Device Sequence Number: 8071273
• Product Code: LZO
• UDI-Device Identifier: 07630030812118
• UDI-Public: 07630030812118
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01.32.3644HCT
• Device Lot Number: 2337865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• 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: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian