MAUDE Adverse Event Report: Medacta International SA Mpact Acetabular System; Hooded PE HC liner Ø36/G

Model Number	01.32.3652HCAT
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 months from the primary,the patient came in due to signs of infection.The surgeon performed a washout and removed theliner and thecompetitor head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 20 july 2026 liner: mpact 01.32.3652hcat hooded pe hc liner d 36/g (b)(6) lot 2501278: (b)(4) items manufactured and released on 11-mar-2025.Expiration date: 20-feb-2030.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 approximately six weeks after primary cementless tha, the patient presented with an early postoperative infection and underwent washout with exchange of the polyethylene liner and femoral head.The reported medacta component was the mpact hooded pe liner; the femoral stem and head were manufactured by depuy.The available ap radiographs are not dated but show a reduced right hip arthroplasty without evident component breakage, dislocation, periprosthetic fracture, or gross migration.Multiple radiopaque beads visible around the proximal femur in one image are compatible with local antibiotic treatment following debridement.Early periprosthetic joint infection is a known postoperative complication and cannot be attributed to a specific implant based on the available clinical and radiographic information.No device was available for direct investigation.There are no elements suggesting malfunction or abnormal performance of the medacta liner.Root cause: infection is a known potential complication of any surgical procedure.Based on the information available, no definitive root cause can be established; however, there is no indication that any issue with the medacta liner caused or contributed to the event.Furthermore, the document review did not identify any potentially related manufacturing issue.

• Brand Name: Mpact Acetabular System
• Common Device Name: Hooded PE HC liner Ø36/G
• 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: 50114121
• Report Number: 3005180920-2026-00774
• Device Sequence Number: 5468340
• Product Code: LPH
• UDI-Device Identifier: 07630030812149
• UDI-Public: 07630030812149
• Combination Product (Y/N): N
• PMA/510(K) Number: K132879
• 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
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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: 01.32.3652HCAT
• Device Lot Number: 2501278
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2025
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Race: White