MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; FLAT PE HC LINER Ø 32 / D

Model Number	01.32.3241HCT
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The liner could not be placed into the cup.During liner impaction attempts, the cup changed position, so it had to be repositioned and the screw already placed was removed.Cup was well fixed and was implanted with no screw, as the orientation of the screw holes made drilling difficult.A new liner was used and the surgery was completed successfully.About 20 minutes delay occurred due to the issue; total surgery time 2 hours.
Additional Manufacturer Narrative
Batch review performed on 20 september 2024: lot 2310238: (b)(4) items manufactured and released on 13-jun-2023.Expiration date: 2028-may-21.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 implant involved, batch review performed on 20 september 2024: cup: mpact 01.32.150dh acetabular shell ø50 two-holes (k132879) lot 2349366: (b)(4) items manufactured and released on 17-jun-2024.Expiration date: 2029-may-30.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.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: FLAT PE HC LINER Ø 32 / D
• 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: 20479341
• Report Number: 3005180920-2024-00843
• Device Sequence Number: 8166410
• Product Code: LPH
• UDI-Device Identifier: 07630030811876
• UDI-Public: 07630030811876
• 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
• Report Date (Section B): 10/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01.32.3241HCT
• Device Lot Number: 2310238
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian