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 Loose or Intermittent Connection (1371)

Patient Problem Unspecified Infection (1930)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21-aug-2020 lot 165961: (b)(4) items manufactured and released on 23-nov-2016.Expiration date: 06-nov-2021.No anomalies found related to the problem.To date, 35 items of the same lot have been already sold without any other similar reported event.

Event Description

The patient had a primary surgery on (b)(6) 2017.On (b)(6) 2017, the patient fell and fractured her lesser trochanter which caused the stem to subside.The surgeon revised the stem, head with another company's product and revised the liner with another medacta liner.On (b)(6) 2017, the patient came in due to signs of infection and the pathogen was enterobacter cloacae.The surgeon washed out the hip and swapped the head of another company and the medacta liner.The surgery was completed successfully.Presently, on (b)(6) 2020, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the competitor head and medacta liner.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: 10507102
• MDR Text Key: 209990248
• Report Number: 3005180920-2020-00595
• 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: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2021
• Device Model Number: 01.26.2848MHC
• Device Catalogue Number: 01.26.2848MHC
• Device Lot Number: 165961
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2016
• 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 Age: 49 YR