MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL TRAY SIZE 1 R

Model Number 02.09.4001R

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 25 march 2022: lot 120877: (b)(4) items manufactured and released on 19-jun-2012.Expiration date: 2017-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 2018.Additional item involved in the event, batch review performed on 25 march 2022: gmk-hinge 02.09.0112h fixed tibial insert size 1/12mm (k130299) lot.143001.Lot 143001: (b)(4) items manufactured and released on 28-aug-2014.Expiration date: 2019-06-30.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 since 2018.

Event Description

The patient came in reporting pain and the cause of the pain is unknown.The surgeon revised the competitor patella, medacta tibial tray, and medacta poly 4 years and 11 months after primary.The surgery was completed successfully.

• Brand Name: GMK-HINGE FIXED TIBIAL TRAY SIZE 1 R
• Type of Device: FIXED TIBIAL TRAY
• 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: 13963189
• MDR Text Key: 288274023
• Report Number: 3005180920-2022-00208
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825521
• UDI-Public: 07630030825521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 02.09.4001R
• Device Catalogue Number: 02.09.4001R
• Device Lot Number: 120877
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2012
• 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 Sex: Female