MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT 3D METAL; MPACT 3D METAL SHELL TWO HOLE Ø52MM

Model Number	01.38.052DH
Medical Device Problem Codes	Osseointegration Problem (3003); Positioning Problem (3009)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 march 2026: lot 2306932: (b)(4) items manufactured and released on 05-may-2023.Expiration date: 2028-apr-18.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.Conclusion: aseptic loosening is possible literature described adverse event after primary hip arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event and the investigation does not indicate any potential manufacturing related issue or systemic deficiency.It was reported by the agent that an fibrous buildup (caused originially by a suboptimal positioning of the shell) in the joint could have contributed to the implant loosening, but there is no confirmation that this could be the reason for revision and patient pain and successive loosening.
Event or Problem Description
The patient had pain as a result of a loose cup.At about 2 years and 8 months post primary the surgeon revised the medacta cup and liner to a competitor cup and liner, and revised the medacta cocr ø36mm head to a medacta 28mm biolox option head with sleeve.The surgery was completed successfully.It was reported by the agent that an fibrous buildup (caused originially by a suboptimal positioning of the shell) in the joint could have contributed to the implant loosening, but there is no confirmation that this could be the reason for revision and patient pain and successive loosening.

• Brand Name: MPACT 3D METAL
• Common Device Name: MPACT 3D METAL SHELL TWO HOLE Ø52MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 24911611
• Report Number: 3005180920-2026-00293
• Device Sequence Number: 18610431
• Product Code: LPH
• UDI-Device Identifier: 07630030812590
• UDI-Public: 07630030812590
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: 01.38.052DH
• Device Lot Number: 2306932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2023
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Race: White