MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 5/20MM; KNEE REVISION INSERT

Model Number 02.09.0520H

Device Problem Device Appears to Trigger Rejection (1524)

Event Date 12/22/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 19 december 2022: lot 182059: (b)(4) items manufactured and released on 26-june-2018.Expiration date: 2023-06-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Addtional component involved: gmk-hinge 02.09.He20 gmk-hinge hinge post extension 20 mm -tinbn coated (k210010) lot.2011024: (b)(4) items manufactured and released on 05-feb-2021.Expiration date: 2026-01-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

Event Description

The patient had a primary knee surgery on (b)(6) 2022.Subsequently, the patient came in reporting pain due to the knee incision opening up during physical therapy.On (b)(6) 2022, the surgeon performed a washout and swapped the poly.On (b)(6) 2022, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the poly and post extension.The surgery was completed successfully.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 5/20MM
• Type of Device: KNEE REVISION INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16061012
• MDR Text Key: 306263018
• Report Number: 3005180920-2022-00980
• Device Sequence Number: 1
• Product Code: KRO
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2023
• Device Model Number: 02.09.0520H
• Device Catalogue Number: 02.09.0520H
• Device Lot Number: 182059
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2018
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White