MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L

Catalog Number	02.12.0414FL
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 july 2018; lot 163056: (b)(4) items manufactured and released on 22 august 2016.Expiration date: 2021-07-27.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.Other device involved: gmk-sphere tibial tray fixed cemented size 4 l reference 02.07.1204l (k090988); lot 173672: (b)(4) items manufactured and released on 06 october 2017.Expiration date: 2022-09-26; 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; 3.5 years after primary cemented tka the tibial component was revised because the patient complained of tightness.A tibial recut was therefore probably performed.There is no reason to think that such an occurrence may be related to a malfunctioning device.
Event or Problem Description
About 3 years and a half after primary the surgeon revised the patient knee tibial components for knee tightness in flexion/extension.The surgery was completed successfully.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 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: 7698437
• Report Number: 3005180920-2018-00512
• Device Sequence Number: 10988826
• Product Code: JWH
• UDI-Device Identifier: 07630030826610
• UDI-Public: 07630030826610
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• 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: 07/27/2021
• Device Catalogue Number: 02.12.0414FL
• Device Lot Number: 163056
• 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: 42 YR