MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L

Catalog Number	02.12.0211FL
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 23 march 2018.One (1) year and 8 months after primary tkr the insert fixation screw got loose in the joint.It was immediately removed with an arthroscopic operation.No consequence should be expected for the absence of the screw in the future life of the implant.The cause for self-unscrewing of the insert screw is not known: one possibility is insufficient tightening torque, but other unknown conditions may also play a role.Batch review performed on 03 april 2018.(b)(4).Preliminary investigation based in the picture of the explanted insert fixation screw performed by r and d product manager on 05 april 2018: loosened insert safety screw occurred about 20 months after primary surgery removed by arthroscopy.No details relevant for the event can be noted looking at the picture of the explanted screw.No other components have been removed.The most-likely cause for self-unscrewing of the screw after few months from implantation, was insufficient tightening torque.
Event or Problem Description
Inlay locking screw arthroscopic removal due to unscrewing after 1 year and 8 months from primary.Torque limiter screwdriver was not used during primary surgery.
Additional Manufacturer Narrative
Visual inspection of the explanted insert fixation screw performed on 23 may 2018 by r&d product manager: loosened insert safety screw occurred about 1 year and 8 months after primary surgery removed by arthroscopy.The head and the threaded part of the screw looks partially damaged.Threads have been plastically 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 arthroscopy 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 2/11 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: 7402521
• Report Number: 3005180920-2018-00209
• Device Sequence Number: 723210
• Product Code: JWH
• UDI-Device Identifier: 07630030862526
• UDI-Public: 07630030862526
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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: 05/31/2020
• Device Catalogue Number: 02.12.0211FL
• Device Lot Number: 151937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 05/30/2018
• 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: 59 YR
• Patient Weight: 71