MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; ACETABULAR SHELL Ø54 TWO-HOLES T

Model Number	01.32.154DHT
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Two months after the primary surgery, the patient returned due to pain.The surgeon discovered that the acetabular cup had spun and become vertical.A multi-hole cup was implanted with two 25 mm screws, and the head and liner were revised.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 01 december 2025.Cup: mpact 01.32.154dht acetabular shell d 54 two-holes t (k230011).Lot.2505208: (b)(4) items manufactured and released on 07 may 2025.Expiration date: 22 april 2030.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.Clinical evaluation, a few weeks after the primary cementless tha, the acetabular cup tilted and required replacement with a model equipped with bone screws.The cause of this event is most likely related to insufficient primary stability, possibly due to inadequate press-fit or poor bone quality.Another possible explanation is an accidental, quasi-traumatic event (not reported), potentially occurring during rehabilitation, which may have subjected the implant-bone interface to excessive early forces before secondary fixation could take place.There is no indication to suspect a faulty implant.Root cause: although the root cause cannot be definitively confirmed, the tilting of the acetabular cup was likely related to insufficient primary stability and, consequently, to low resistance to forces acting during the early postoperative stages.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: ACETABULAR SHELL Ø54 TWO-HOLES T
• 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: 23837280
• Report Number: 3005180920-2025-01219
• Device Sequence Number: 12028975
• Product Code: LPH
• UDI-Device Identifier: 07630345798763
• UDI-Public: 07630345798763
• Combination Product (Y/N): N
• PMA/510(K) Number: K230011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 12/18/2025

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: 01.32.154DHT
• Device Lot Number: 2505208
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2025
• 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