MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R

Catalog Number	02.12.0212FR
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 july 2018; lot 164443: (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 preliminary investigation of the picture of the explanted insert and its secure fixation screw performed by 18 july 2018 by r&d product manager loosened insert safety screw occurred about 1 year after primary surgery and removed during revision surgery.Tibial insert was found damaged and substituted.The head and the threaded part of the screw looks partially damaged.They 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.Loosened screw caused also: - some dents and scratches on the articular surface of the tibia insert that was then removed and substituted with a thicker one - some metal debris that can be noted on the articular surface of the tibia insert.Tibia 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 (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
The screw had backed out and got lodged between the poly and the femoral component 1 year after primary.The surgeon removed the screw and the poly, did an extensive debridement, trialed different size poly and decided to go from a 12 to a 14mm poly.The femur, tibia and patella were all well fixed.The surgery was completed successfully.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 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: 7698440
• Report Number: 3005180920-2018-00515
• Device Sequence Number: 1049854
• Product Code: JWH
• UDI-Device Identifier: 07630030826184
• UDI-Public: 07630030826184
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2018

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: 10/19/2016
• Device Catalogue Number: 02.12.0212FR
• Device Lot Number: 164443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/18/2018
• 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: 46 YR