MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; MPACT ACETABULAR SHELL Ø46 TWO-HOLES T

Catalog Number	01.32.146DHT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 20 april 2026: cup: mpact 01.32.146dht acetabular shell ø46 two-holes t (k250450) lot 2338374: (b)(4) items manufactured and released on 11-mar-2024.Expiration date: 25-feb-2029.No anomalies found related to the problem.To date, 16 items of the same lot have been sold with no similar reported event during the period of review.Liner: mpact 01.32.3239hct flat pe hc liner ø32/c (k103721) lot 2339884: (b)(4) items manufactured and released on 06-dec-2023.Expiration date: 05-nov-2028.Expiration date: 05-nov-2028.No anomalies found related to the problem.To date, 90 items of the same lot have been sold with no similar reported event during the period of review.Ball heads: mectacer 01.29.205 mectacer head biolox delta dia.32 12/14-m (k112115) lot 2404439: (b)(4) items manufactured and released on 07-mar-2024.Expiration date: 17-feb-2029.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.Root cause: based on the information available, no definitive root cause can be established.Hip instability may occur due to numerous application-specific factors, however no particular issues were reported in this case.Although a root cause could not be identified, the investigation does not indicate any potential manufacturing related issue or systemic deficiency.This patient had a following revision sugery that will be reported.
Event or Problem Description
The patient had hip instability and the cause is unknown.There was no trauma or bone quality issues reported.At about 1 year and 9 months post primar the surgeon revised the medacta cup and liner to a competitor cup and liner.The surgeon also revised the 32 mm biolox head m to a 36 mm biolox head s.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: MPACT ACETABULAR SHELL Ø46 TWO-HOLES T
• 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: 25729356
• Report Number: 3005180920-2026-00697
• Device Sequence Number: 16090569
• Product Code: LZO
• UDI-Device Identifier: 07630345798688
• UDI-Public: 07630345798688
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K250450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/07/2026

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 Catalogue Number: 01.32.146DHT
• Device Lot Number: 2338374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• 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: 51 YR
• Patient Sex: Female
• Patient Race: White