MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 01.32.152MB DOUBLE MOBILITY ACETABULAR SHELL Ø52; HIP DOUBLE MOBILITY ACETABULAR SHELL

Model Number 01.32.152MB

Device Problem Malposition of Device (2616)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/17/2023

Event Type  Injury  

Event Description

At about 2 years and 10 months after the primary surgery, the surgeon observed that the patient had a malpositioned cup and the cause of the malpositioning is unknown.The surgeon revised the medacta cup and liner with competitor components and revised the medacta head with a medacta head.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 06-jun-2023.Lot 2001266: (b)(4) items manufactured and released on 11-may-2020.Expiration date: 2025-04-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: CUP: MPACT 01.32.152MB DOUBLE MOBILITY ACETABULAR SHELL Ø52
• Type of Device: HIP DOUBLE MOBILITY ACETABULAR SHELL
• 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: 17144072
• MDR Text Key: 317330143
• Report Number: 3005180920-2023-00437
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030860973
• UDI-Public: 07630030860973
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01.32.152MB
• Device Catalogue Number: 01.32.152MB
• Device Lot Number: 2001266
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female