MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L

Catalog Number	02.12.0313FL
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 july 2018.Lot 143215: (b)(4) items manufactured and released on 02 october 2014.Expiration date:2022-11-23.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 by medical affairs director on 18 july 2018.The insert fixation screw in a cemented medial pivot tka backed out after 2.5 years and required removal.No negative consequence should be expected in absence of said screw.The causes for this event cannot be determined retrospectively: such behaviour was reproduced in vitro using insufficient tightening torque, but it is conceivable that other factors may also playa a role.
Event or Problem Description
Revision surgery due to screw back out 2 years and 6 months after primary.The surgeon removed screw and poly and implanted a new poly 1mm thicker without screw.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7698434
• Report Number: 3005180920-2018-00514
• Device Sequence Number: 19270886
• Product Code: JWH
• UDI-Device Identifier: 07630030862571
• UDI-Public: 07630030862571
• 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: 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: 11/23/2022
• Device Catalogue Number: 02.12.0313FL
• Device Lot Number: 143215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• 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: 50 YR