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

Catalog Number 01.26.2852MHC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 6 september 2019.Lot 1810745: (b)(4) items manufactured and released on 15-feb-2019.Expiration date: 2024-01-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

On 28 august 2019, we were informed that a revision would take place on (b)(6) 2019, more than 2 months after primary surgery, because the patient came in complaining of pain.The cause of the pain is unknown.The surgeon did not remove any components from the patient.The surgeon performed an open reduction external fixation of the left femur and inserted a plate into the patient.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMF
• 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: 9109178
• MDR Text Key: 162311638
• Report Number: 3005180920-2019-00811
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2024
• Device Catalogue Number: 01.26.2852MHC
• Device Lot Number: 1810745
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2019
• 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