MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 52/28; DOUBLE MOBILITY LINER

Model Number 01.26.2852MHC

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

Patient Problem Unspecified Infection (1930)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 11 december 2020 lot 2001457: 110 items manufactured and released on 23-jun-2020.Expiration date: 2025-06-02.No anomalies found related to the problem.To date, 61 items of the same lot have been already sold without any similar reported event.Additional item involved in the event: ball heads: cocr 01.25.011 cocr ball head 12/14 ø 28 size s -3.5 (k072857) lot.2001935 batch review performed on 11 december 2020 lot 2001935: 120 items manufactured and released on 22-jun-2020.Expiration date: 2025-06-08.No anomalies found related to the problem.To date, 49 items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in after 1 month from the 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 52/28
• Type of Device: 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: 11037519
• MDR Text Key: 227476265
• Report Number: 3005180920-2020-00956
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01.26.2852MHC
• Device Catalogue Number: 01.26.2852MHC
• Device Lot Number: 2001457
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2020
• 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