MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SCSIZE 4/10MM; TIBIAL INSERT FIXED

Model Number 02.07.0410SCF

Device Problems Material Rupture (1546); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 04/08/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 20 april 2020: lot 162517: (b)(4) items manufactured and released on 22-aug-2016.Expiration date: 2021-07-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

The patient came in reporting pain due to rupturing the patella tendon during physical therapy.The surgeon revised the poly 3 weeks after primary.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SCSIZE 4/10MM
• Type of Device: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 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: 10031880
• MDR Text Key: 192253378
• Report Number: 3005180920-2020-00275
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030817656
• UDI-Public: 07630030817656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103170
• 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: 05/07/2020

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: 07/25/2021
• Device Model Number: 02.07.0410SCF
• Device Catalogue Number: 02.07.0410SCF
• Device Lot Number: 162517
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 05/07/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2016
• 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