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 Code	Aseptic loosening (4883)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to acetabular cup loosening after about 2 years and 10 months from primary.The patient stated that pain began after standing from a seated position.The surgeon revised the medacta acetabular cup and liner with a competitor cup and liner and revised the 36mm biolox head l to a 28mm biolox option head with sleeve.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 27 april 2026 lot 2243094: (b)(4) items manufactured and released on 09-jan-2023.Expiration date: 2027-dec-14.No anomalies found related to the problem.To date, 31 items of the same lot have been sold with no similar reported event during the period of review.Root cause:aseptic loosening is a possible literature-described adverse event after primary hip arthroplasties and causes are often unknown and in this case, 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.

• 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: 25123191
• Report Number: 3005180920-2026-00417
• Device Sequence Number: 10729119
• 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: 2023
• 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): 05/08/2026

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: 2243094
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• 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: 84 YR
• Patient Sex: Female