MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; MPACT ACETABULAR SHELL Ø 52 TWO-HOLES

Model Number	01.32.152DH
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 april 2025: lot 2109424: (b) (4) items manufactured and released on 04-nov-2021.Expiration date: 2026-10-21.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional device involved: batch review performed on 16 april 2025: stem: masterloc 01.39.005 cementless ti coated std stem size 5 (k151531) lot 184730: (b)(4) items manufactured and released on 08-nov-2018.Expiration date: 2023-10-30.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 performed by clinical affairs manager: a revision surgery was performed three years after the primary total hip arthroplasty (tha).The patient reported pain, and follow-up radiographs revealed areas of bone resorption affecting both the acetabulum and the femur.Based on the available x-ray images, the bone loss around the acetabulum appears consistent with osteolysis, while the resorption in the femur is localized to the greater trochanter and seems indicative of a stress shielding phenomenon.Determining the exact cause of these findings is challenging given the limited clinical information.It has been reported that the implants-particularly on the acetabular side-were loosened.Aseptic loosening is a well-documented complication of tha, though its underlying etiology often remains unclear.At present, there is insufficient evidence to draw definitive conclusions.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.
Event or Problem Description
At 3 years 1 month from the primary, the patient came in reporting pain and the surgeon observed bone loss around the cup and stem.The cup came out easily, the stem had one spot that was difficult to release, and the liner looked normal.The surgeon decided to revise the cup, head, liner and stem.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: MPACT ACETABULAR SHELL Ø 52 TWO-HOLES
• 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: 22008281
• Report Number: 3005180920-2025-00408
• Device Sequence Number: 7923699
• Product Code: LZO
• UDI-Device Identifier: 07630030810794
• UDI-Public: 07630030810794
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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): 05/13/2025

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: 01.32.152DH
• Device Lot Number: 2109424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: White