MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 10 MM; FIXED KNEE TIBIAL INSERT

Model Number 02.07.0310FUC

Device Problem Material Integrity Problem (2978)

Patient Problem Joint Disorder (2373)

Event Date 04/15/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 27-apr-2020: lot 130892: (b)(4) items manufactured and released on 11-apr-2013.Expiration date: 28-feb-2018.No anomalies found related to the problem to date, all items of the same lot have been already sold without any other similar reported event since 2016.Clinical evaluation performed by medical affairs director: 7 years after primary cemented tka in a morbidly obese woman of unspecified age, the polyethylene insert is found worn posteriorly and replaced.No pictures are available.A bmi of (b)(6) is a condition that may affect longevity of tja, as specified in instructions for use.We do not think that this wear in 7 years can be attributed to a defective device.

Event Description

The patient came in reporting instability and pain 6 years and 7 months after the primary surgery.The surgeon revised the medacta tibial insert u.C.Fix s.3 / 10 mm with a medacta insert u.C.14mm s3.It was observed that the femoral and tibial components were stable, and the surgeon left them remaining.The surgery was completed successfully.Looking at the inlay removed, poly wear was suspected on the posterior side of the implant.

• Brand Name: GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 10 MM
• Type of Device: FIXED KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 10055401
• MDR Text Key: 192254992
• Report Number: 3005180920-2020-00281
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030817038
• UDI-Public: 07630030817038
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/14/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 02.07.0310FUC
• Device Catalogue Number: 02.07.0310FUC
• Device Lot Number: 130892
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2020
• Initial Date FDA Received: 05/14/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 154