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

Model Number 01.26.2858MHC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21 september 2020.Lot 1908432: (b)(4) items manufactured and released on 13-dec-2019.Expiration date: 2024-12-01.No anomalies found related to the problem.To date, 21 items of the same lot have been already sold without any similar reported event.Additional device involved: ball heads: mectacer 01.29.203 biolox delta ceramic ball head 12/14 ø 28 size l +3.5 (k112115) lot.1908980.Batch review performed on 21 september 2020.Lot 1908980: (b)(4) items manufactured and released on 10-feb-2020.Expiration date: 2025-01-21.No anomalies found related to the problem.To date, 42 items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in, 2 months after primary surgery, due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMI
• Type of Device: ACETABULAR LINER DOUBLE MOBILITY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 10647876
• MDR Text Key: 210408908
• Report Number: 3005180920-2020-00697
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807442
• UDI-Public: 07630030807442
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01.26.2858MHC
• Device Catalogue Number: 01.26.2858MHC
• Device Lot Number: 1908432
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2019
• 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