MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM

Catalog Number 02.09.0412H

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hematoma (1884)

Event Date 09/24/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed by medacta regulatory affairs department on 2 october 2019: lot 189415: (b)(4) items manufactured and released on 22-gen-2019.Expiration date: 2024-01-03.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.

Event Description

Revision surgery performed 18 days after the primary due to pain due to a hematoma in the knee.The cause of the hematoma is unknown.The surgeon performed a washout and inlay swap successfully.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM
• Type of Device: FIXED 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: 9232329
• MDR Text Key: 173184441
• Report Number: 3005180920-2019-00895
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825194
• UDI-Public: 07630030825194
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2024
• Device Catalogue Number: 02.09.0412H
• Device Lot Number: 189415
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2019
• 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