MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R; KNEE IMPLANT. TIBIAL INSERT FIXED FLEX

Model Number 02.12.0410FR

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 10 february 2020: lot 1903267: (b)(4) items manufactured and released on 08-july-2019.Expiration date: 2024-06-23.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

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

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R
• Type of Device: KNEE IMPLANT. TIBIAL INSERT FIXED FLEX
• 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: 9768789
• MDR Text Key: 189881573
• Report Number: 3005180920-2020-00102
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030826542
• UDI-Public: 07630030826542
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.12.0410FR
• Device Catalogue Number: 02.12.0410FR
• Device Lot Number: 1903267
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2019
• 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