MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/13 MM R

Catalog Number	02.12.0211FR
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported by the field, no torque limiter used in primary surgery.Batch review performed on 23 august 2018.Lot.164442: (b)(4) items manufactured and released on 19 october 2016.Expiration date: 2021-09-19 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.Clinical evaluation performed on 23 august 2018.Sixteen (16) months after primary tka 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.During arthroscopic surgery, implant surfaces can be visualized and checked for damages.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.Visual inspection of the explanted tibial insert secure fixation screw on 23 august 2018 by r and d product manager: loosened insert safety screw occurred about 1 year and 4 months after primary surgery and removed by arthroscopy.The head and the threaded part of the screw looks partially damaged.They have most likely 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.Tibial insert, tibial baseplate and femoral components have not been explanted, so we can suppose that they have been found in good condition.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.But other unknown factors might also play a role in the event.No further considerations can be done basing on the available information.
Event or Problem Description
Patient presented 16 months post surgery right total knee replacement sphere knee.Tibial insert screw backout noted on x ray.Patient had screw removed arthroscopically under a general anaesthetic.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/13 MM R
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7809075
• Report Number: 3005180920-2018-00631
• Device Sequence Number: 19199716
• Product Code: JWH
• UDI-Device Identifier: 07630030862540
• UDI-Public: 07630030862540
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2018

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: 09/19/2021
• Device Catalogue Number: 02.12.0211FR
• Device Lot Number: 164442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 08/23/2018
• 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: 65 YR
• Patient Weight: 62