MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R; KNEE TIBIAL INSERT FIXED

Model Number 02.12.0410FR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Implant Pain (4561)

Event Date 04/05/2023

Event Type  Injury  

Event Description

The patient came in reporting pain, and the surgeon suspected that foreign bodies were present in the body.About 2 years after the primary surgery, the surgeon operated on the patient and did not discover anything but decided to perform a washout and poly swap.The surgery was completed successfully.No signs of infection were present.

Manufacturer Narrative

Batch review performed on (b)(6) 2023.Lot 2002793: (b)(4) items manufactured and released on 23-jun-2020.Expiration date: 2025-jun-02.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R
• Type of Device: KNEE TIBIAL INSERT FIXED
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16859026
• MDR Text Key: 314437555
• Report Number: 3005180920-2023-00319
• 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: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• 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: 2002793
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2020
• 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 Sex: Female