MAUDE Adverse Event Report: Medacta International SA Mpact Acetabular System; Flat PE HC liner Ø40/F

Model Number	01.32.4048HCT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The initial canal finder and subsequent broaches exited through the posterior femoral cortex.No bone fracture was reported.The femur was subsequently re-broached and prophylactic cables were applied to reduce the risk of postoperative fracture.At the end of the primary procedure, the hip was considered stable by the surgeon.However, a postoperative dislocation of the femoral head from the cup/liner construct occurred in the recovery area on the same day.The patient subsequently underwent revision surgery due to pain associated with the dislocation.During revision, the d 40/f flat pe hc liner was replaced with a d 40/f 10° face-changing pe hc liner.The revision procedure was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 21 august 2026: 01.32.4048hct flat pe hc liner d 40/f (k122641) lot 2601047: (b)(6) items manufactured and released on 26-feb-2026.Expiration date: 02-feb-2031.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold with no similar reported event during the period of review.01.29.213 mectacer head biolox delta dia.40 12/14-m (k112115) lot 2611014: (b)(6) items manufactured and released on 18-may-2026.Expiration date: 23-apr-2031.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold with no similar reported event during the period of review.Root cause:based on the information available, no definitive root cause can be established.The recurrent dislocation may have been related to case-specific clinical factors affecting joint stability, such as inadequate soft-tissue tension or component orientation; however, these factors cannot be confirmed from the available documentation and radiographic evidence.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 potentially related manufacturing issue.

• Brand Name: Mpact Acetabular System
• Common Device Name: Flat PE HC liner Ø40/F
• 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: 50474961
• Report Number: 3005180920-2026-00897
• Device Sequence Number: 10112864
• Product Code: LZO
• UDI-Device Identifier: 07630030812262
• UDI-Public: 07630030812262
• Combination Product (Y/N): N
• PMA/510(K) Number: K122641
• 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): 08/27/2026

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: 01.32.4048HCT
• Device Lot Number: 2601047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2026
• 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: 62 YR
• Patient Sex: Male