MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; ACETABULAR SHELL Ø48 NO-HOLE

Model Number	01.32.148SH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Impingement (4834)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 june 2026 lot 2109431: (b)(4) items manufactured and released on 27-dec-2021.Expiration date: 14-oct-2026.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.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
The patient came in presenting pain due to cup - iliopsoas impingement and the cause is unknown.It has been reported that probably the cup was not medialized enough and has been malpositioned, but there is no confirmation of this information.About 4 years after the primary surgery, the surgeon revised the medacta cup and liner to competitor implants and revised the head with an l size and sleeve.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: ACETABULAR SHELL Ø48 NO-HOLE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25763493
• Report Number: 3005180920-2026-00706
• Device Sequence Number: 13208344
• Product Code: LPH
• UDI-Device Identifier: 07630030810756
• UDI-Public: 07630030810756
• Combination Product (Y/N): N
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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: 01.32.148SH
• Device Lot Number: 2109431
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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