MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM LINER; ACETABULAR PE LINER

Catalog Number 01.26.2852MHC

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 07/09/2018

Event Type  Injury  

Manufacturer Narrative

On 19 july 2018 the medical affairs manager made the following analysis: early infection in cementless tha, 3 months after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Batch review performed on 26 july 2018.Lot 177528: 110 items manufactured and released on 20 february 2018.Expiration date: 2023-02-04.No anomalies found related to the problem.To date, 74 items of the same lot have been already sold with one similar reported event.

Event Description

About 3 months after primary the surgeon revised the patient for an infection (e-coli).Liner swap.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DM LINER
• Type of Device: ACETABULAR PE LINER
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7731862
• MDR Text Key: 115409130
• Report Number: 3005180920-2018-00579
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807343
• UDI-Public: 07630030807343
• 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: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2023
• Device Catalogue Number: 01.26.2852MHC
• Device Lot Number: 177528
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2018
• 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