MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; MPACT FLAT PE HC LINER Ø28/B

Model Number	01.32.2837HCT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 jul 2025: lot 185979: (b)(4) items manufactured and released on 25-sept-2018.Expiration date: 2023-09-03.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.The surgeon revised liner height, which is a common practice to restore the joint stability.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
At 5 years 2 months from the primary, the patient came in reporting instability and the cause of the instability is unknown.The surgeon revised the flat pe hc liner to a face change 10° pe hc liner.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: MPACT FLAT PE HC LINER Ø28/B
• 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: 22518827
• Report Number: 3005180920-2025-00671
• Device Sequence Number: 18301099
• Product Code: LZO
• UDI-Device Identifier: 07630030811531
• UDI-Public: 07630030811531
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 07/16/2025

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: 09/03/2023
• Device Model Number: 01.32.2837HCT
• Device Lot Number: 185979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2018
• 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: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White