MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/14MM; KNEE REVISION TIBIAL INSERT

Model Number 02.09.0414H

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 04/21/2022

Event Type  Injury  

Event Description

At about 11 months after the primary, revision surgery following infection.The surgeon revised successfully the insert.

Manufacturer Narrative

Batch review performed on 02 may 2022.Lot 1906393: (b)(4) items manufactured and released on 13-sep-2019.Expiration date: 2024-08-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 4/14MM
• Type of Device: KNEE REVISION 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: 14407317
• MDR Text Key: 291721486
• Report Number: 3005180920-2022-00381
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825200
• UDI-Public: 07630030825200
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K130299
• 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: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.09.0414H
• Device Catalogue Number: 02.09.0414H
• Device Lot Number: 1906393
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2019
• 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: 84 YR
• Patient Sex: Female