MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT 3D METAL; MPACT 3D METAL SHELL TWO HOLE Ø54MM

Model Number	01.38.054DH
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department: the complaint describes an early revision of a cementless tha approximately 8.5 months after primary implantation due to acetabular cup loosening, with radiographic radiolucency around the cup and a cranial gap between the acetabular bone and shell.In the context of coxa profunda with a very thin medial acetabular wall, this finding may suggest challenging acetabular anatomy with reduced structural support, potentially contributing to suboptimal initial seating, insufficient press-fit stability, micromotion, and failure of successful osseointegration.However, the exact root cause cannot be determined with the available information and there is currently no confirmed evidence of device malfunction or manufacturing defect.Batch review performed on 06 may 2026 cup: mpact 3d metal 01.38.054dh mpact 3d metal shell two hole d 54mm (k171966) lot 2417821: (b)(4) items manufactured and released on 29-jul-2024.Expiration date: 11-jul-2029.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: aseptic loosening is possible literature described adverse event after primary hip arthroplasties and causes are often unknown.The event may be related to case-specific clinical and anatomical factors, including coxa profunda with a very thin medial acetabular wall, which may have reduced acetabular structural support and contributed to suboptimal initial seating, insufficient press-fit stability, micromotion, and unsuccessful osseointegration of the cementless cup.The device history record review did not identify any potentially related manufacturing anomaly.
Event or Problem Description
At about 9 months from the primary, the patient came in presenting mild pain due to a loose cup and the cause is unknown.There was no trauma or infection indicated.After an orthopedic surgeon observation, the cup loosening had increased.The surgeon revised the amistem-p collared size 3 to a quadra-p cemented size 2, the 36mm biolox head s to an head l, the hooded pe hc liner d 36/e to a d 36/f, and the mpact 3d metal shell two hole d 54mm to a multi hole d 60mm.The surgery was completed successfully.

• Brand Name: MPACT 3D METAL
• Common Device Name: MPACT 3D METAL SHELL TWO HOLE Ø54MM
• 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: 25328462
• Report Number: 3005180920-2026-00476
• Device Sequence Number: 18593286
• Product Code: LPH
• UDI-Device Identifier: 07630030812606
• UDI-Public: 07630030812606
• Combination Product (Y/N): N
• PMA/510(K) Number: K171966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 05/29/2026

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: 01.38.054DH
• Device Lot Number: 2417821
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2024
• 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