MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT FIXED SIZE 2 / 14 MM; KNEE TIBIAL INSERT FIXED

Catalog Number	02.07.0214FUC
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 march 2019: lot 134898: (b)(4) items manufactured and released on 16 january 2014.Expiration date: 2018-11-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 3 similar reported events (b)(4).Other devices were involved in the complaint: gmk-primary 02.07.1202l tibial tray fixed cemented size 2 l lot.154442 (k090988): (b)(4) items manufactured and released on 30-nov-2015.Expiration date: 2020-11-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar event reported.Gmk-primary 02.07.2002l femur std cemented size 2 l lot.131810 (k090988): (b)(4) items manufactured and released on 27-jun-2013.Expiration date: 2018-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar event reported.Clinical evaluation performed by medical affairs manager: revision in tka 2 years and 3 months after primary for joint instability.The surgeon decided to replace the implant to increase soft tissue tension and knee stability.The developmental instability is a rather commonly described possible complication following tka, because soft tissue may stretch and provide insufficient stability.This is not a problem due to any implant defect or malfunction.
Event or Problem Description
About 2 years and three months after primary, the surgeon revised the patient for instability due to knee laxity.The cause of laxity is unknown.The surgeon swapped all the hardware successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT FIXED SIZE 2 / 14 MM
• Common Device Name: KNEE TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8456538
• Report Number: 3005180920-2019-00191
• Device Sequence Number: 344473
• Product Code: JWH
• UDI-Device Identifier: 07630030816659
• UDI-Public: 07630030816659
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2019

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: 11/30/2018
• Device Catalogue Number: 02.07.0214FUC
• Device Lot Number: 134898
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/27/2019
• 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