MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE 02.09.0312H FIXED TIBIAL INSERT SIZE 3/12MM; KNEE TIBIAL INSERT

Model Number 02.09.0312H

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 11/18/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 23 november 2022.Lot 2111972: (b)(4) items manufactured and released on 10-dec-2021.Expiration date: 2026-nov-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

Event Description

The patient came in due to signs of an infection and the pathogen is unknown.About 2 months after the primary surgery, the surgeon performed a washout and revised the poly and the surgery was completed successfully.

• Brand Name: GMK-HINGE 02.09.0312H FIXED TIBIAL INSERT SIZE 3/12MM
• Type of Device: KNEE TIBIAL 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: 15977604
• MDR Text Key: 305490131
• Report Number: 3005180920-2022-00925
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825125
• UDI-Public: 07630030825125
• 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: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.09.0312H
• Device Catalogue Number: 02.09.0312H
• Device Lot Number: 2111972
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2021
• 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