MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 R; KNEE TIBIAL TRAY CEMENTED

Model Number 02.07.1203R

Device Problem Malposition of Device (2616)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 03/28/2022

Event Type  Injury  

Event Description

Knee pain, varus misalignment of tibial component and frontal instability lead to the decision for a revision of all components 12 years after the primary.

Manufacturer Narrative

Batch review performed on (b)(6) 2022.Lot 092965: 17 items manufactured and released on (b)(6) 2010.Expiration date: 2014-12-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported since 2018.Clinical evaluation performed by clinical affairs department.At 12 years after primary cemented tka, a revision is undertaken to correct the rather severe postoperative varus angle of the knee joint.We do not know if this situation is an evolution of the post-primary positioning or if it was done in this way since the index surgery; in the latter case, we do not know the reasons for this choice.However, this revision was not caused by a defective or malfunctioning device.

• Brand Name: GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 R
• Type of Device: KNEE TIBIAL TRAY CEMENTED
• 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: 14238356
• MDR Text Key: 290306686
• Report Number: 3005180920-2022-00295
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030819896
• UDI-Public: 07630030819896
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: 02.07.1203R
• Device Catalogue Number: 02.07.1203R
• Device Lot Number: 092965
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2010
• 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 Age: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White