MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R; KNEE TIBIAL INSERT

Model Number 02.12.0310FR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Laxity (4526)

Event Date 01/05/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 12 january 2023: lot: 2106554: (b)(4) items manufactured and released on 03-aug-2021.Expiration date: 2026-jul-14.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 reporting pain and instability and the cause is unknown.About 1 year and 2 months after the primary surgery, the surgeon revised the poly (from 10 mm to 12 mm) and the surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R
• 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: 16232174
• MDR Text Key: 307983999
• Report Number: 3005180920-2023-00028
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030826344
• UDI-Public: 07630030826344
• 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: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.12.0310FR
• Device Catalogue Number: 02.12.0310FR
• Device Lot Number: 2106554
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2021
• 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
• Patient Sex: Female