MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L

Catalog Number	02.12.0413FL
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 may 2018.Lot 143217: 50 items manufactured and released on 26 september 2014 expiration date: 2019-08-31.No anomalies found related to the problem.To date, 29 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
About 3 years after primary the tibial inlay screw come out.The surgeon removed it arthroscopically.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection of the explanted insert fixation screw on 23 may 2018 by r&d product manager: loosened insert safety screw occurred about 2 year and 8 months after primary surgery removed by arthroscopy.The head and the threaded part of the screw looks completely damaged and plastically deformed.Threads have been pressed once, backed out from the baseplate, were interposed between the femoral component and the tibia insert and underwent to the body load.No other components have been removed, so we can suppose that they have been found in good condition during arthoscopy to remove the screw.The most-likely cause for self-unscrewing of the screw after few months from implantation, was insufficient tightening torque.Using a screwdriver provided with a torque limitation (ref.02.07.10.4577; torque limiter screwdriver 3.5 nm) would prevent this event.Torque limiter screwdriver is already available and its use is mandatory.No further considerations can be done basing on the available information.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7486985
• Report Number: 3005180920-2018-00295
• Device Sequence Number: 2222437
• Product Code: JWH
• UDI-Device Identifier: 07630030862618
• UDI-Public: 07630030862618
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 02.12.0413FL
• Device Lot Number: 143217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 80