MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/11 MM L

Model Number 02.12.0611FL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21 july 2022.Lot 179673: (b)(4) items manufactured and released on 25-apr-2018.Expiration date: 2023-apr-13.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

After the primary right knee surgery on (b)(6) 2022, it was observed that a left insert was implanted with a right baseplate.On (b)(6) 2022, the surgeon revised the left insert with the correct right insert.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/11 MM L
• Type of Device: TIBIAL INSERT FIXED
• 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: 15247456
• MDR Text Key: 298114648
• Report Number: 3005180920-2022-00619
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030862687
• UDI-Public: 07630030862687
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140826
• 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: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2023
• Device Model Number: 02.12.0611FL
• Device Catalogue Number: 02.12.0611FL
• Device Lot Number: 179673
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2018
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White