MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY SHELLS; MPACT DM ACETABULAR SHELL Ø50

Model Number	01.32.150MB
Medical Device Problem Codes	Osseointegration Problem (3003); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 may 2026: lot 2510045: (b)(4) items manufactured and released on 29-oct-2025.Expiration date: 2030-oct-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause: based on the information available, no definitive root cause can be established for the reported pain and cup migration.The patient¿s non-adherence to the scheduled post-operative follow-up may have contributed to delayed identification and management of the cup movement; however, the cause of the event remains unknown.The device history record review did not indicate any potentially related manufacturing issue.
Event or Problem Description
The patient had pain that was due to a cup that had moved and the cause is unknown.The patient did not adhere to the follow-up appointment schedule after primary surgery.The surgeon revised the mpact dm d 50 cup to a mpact dm d 54 cup, revised the hc d 28/dme liner to a hc d 28/dmg liner, and revised the 28mm biolox head to a same size head.The surgery was completed successfully.

• Brand Name: MPACT DOUBLE MOBILITY SHELLS
• Common Device Name: MPACT DM ACETABULAR SHELL Ø50
• 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: 25297697
• Report Number: 3005180920-2026-00518
• Device Sequence Number: 15782607
• Product Code: LPH
• UDI-Device Identifier: 07630030860966
• UDI-Public: 07630030860966
• Combination Product (Y/N): N
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/27/2026

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: 01.32.150MB
• Device Lot Number: 2510045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2025
• 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
• Patient Race: White