MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DME; HIP ACETABULAR LINER DOUBLE MOBILITY

Model Number 01.26.2850MHC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 04/11/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21 april 2023.Lot 103050: (b)(4) items manufactured and released on 29-oct-2010.Expiration date: 2015-09-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.

Event Description

At about 12 years 5 months after the primary, the patient came in reporting pain and the surgeon suspected iliopsoas tendon impingement with the dm liner.The surgeon revised the head (upsized to add offset) and liner and the surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DME
• Type of Device: HIP ACETABULAR LINER DOUBLE MOBILITY
• 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: 16868192
• MDR Text Key: 314554234
• Report Number: 3005180920-2023-00343
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807282
• UDI-Public: 07630030807282
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092265
• 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: 05/04/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: 01.26.2850MHC
• Device Catalogue Number: 01.26.2850MHC
• Device Lot Number: 103050
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2010
• 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