MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT 3D METAL ACETABULAR SYSTEM; CUP: MPACT 3D METAL SHELL MULTI HOLE THIN Ø48MM

Model Number	01.38.348MH
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Aseptic loosening (4883)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23-04-2025 lot 2205820: (b)(4) items manufactured and released on 26-04-2022.Expiration date: 2027-04-05.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold with no similar reported event during the period of review.Preliminary investigation performed by r&d department: from the images, it is notable the polyethylene liner inside the shell just explanted; some blood is present on the devices, but as no particular signes are visible it was not possible to determine the root cause of the event.Additional implants involved: batch review performed on 23-04-2025 on stem: m-vizion 01.22.101 distal stem ø12mm l 140mm straight (k170690) lot.2347466 lot 2347466: (b)(4) items manufactured and released on 05-03-2024.Expiration date: 2029-02-18.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold with no similar reported event during the period of review.Batch review performed on 23-04-2025 on stem: m-vizion 01.22.402 proximal body ø20mm l 50mm std with holes (k201471) lot.2414754 lot 2414754: (b)(4) items manufactured and released on 16-09-2024.Expiration date: 2029-09-02.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold with no similar reported event during the period of review.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
Few days after primary surgery it was noticed during a postoperative check that the native acetabulum was perforated leading to a mobilization of the cup.During the revision, the surgeon noticed that the stem was mobilized too.Probably due to the stem being undersized.Surgeon revised all components and surgery was completed successfully.
Additional Manufacturer Narrative
X-rays received on 21 may 2025.Clinical evaluation performed by clinical affairs department: a few days after the implantation of a total hip arthroplasty, intrapelvic displacement of the acetabular cup was identified during postoperative follow-up.Available radiographs clearly demonstrate medial migration of the cup, associated with an acetabular fracture.During revision surgery, stem mobilization was also observed.This finding is supported by one of the available images, which suggests that the distal portion of the stem may have been undersized.Determining the exact cause of this failure is challenging.Multiple factors can contribute to acetabular protrusion, including excessive reaming during socket preparation and poor bone quality.It is even a possibility that the complication originated during the impaction phase, although it is uncertain whether an initial bone breach occurred intraoperatively.Based on the information currently available, no definitive conclusions can be drawn.However, there is no indication to suspect a device defect.Root cause update: 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 ACETABULAR SYSTEM
• Common Device Name: CUP: MPACT 3D METAL SHELL MULTI HOLE THIN Ø48MM
• 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: 22024372
• Report Number: 3005180920-2025-00411
• Device Sequence Number: 12546711
• Product Code: LZO
• UDI-Device Identifier: 07630971212565
• UDI-Public: 07630971212565
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K202568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 06/13/2025

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: 01.38.348MH
• Device Lot Number: 2205820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2022
• 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: Unknown