MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 48/28; ACETABULAR DOUBLE MOBILITY LINER

Model Number 01.26.2848MHC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 08 october 2020, lot 2000166: (b)(4) items manufactured and released on 07-apr-2020.Expiration date: 2025-03-30.No anomalies found related to the problem.To date, 104 items of the same lot have been already sold without any other similar reported event.Additional implant involved: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.1906462.Batch review performed on 08 october 2020, lot 1906462: (b)(4) items manufactured and released on 31-oct-2019.Expiration date: 2024-10-13.No anomalies found related to the problem.To date, 233 items of the same lot have been already sold with 4 other similar events reported on the lot.

Event Description

The patient came in due to signs of infection 14 days after the primary surgery, the pathogen is unknown.The surgeon performed a washout and revised the insert and head.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 48/28
• Type of Device: ACETABULAR DOUBLE MOBILITY LINER
• 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: 10738977
• MDR Text Key: 213186170
• Report Number: 3005180920-2020-00753
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807244
• UDI-Public: 07630030807244
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01.26.2848MHC
• Device Catalogue Number: 01.26.2848MHC
• Device Lot Number: 2000166
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2020
• 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