MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA EVOLIS TIBIAL INSERT UC FLEX SIZE3 13 MM; KNEE TIBIAL INSERT

Catalog Number 3046.0313

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Laxity (4526)

Event Date 01/16/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 01 february 2024: lot 081379: (b)(4) items manufactured and released on 18-jan-2008.Expiration date: 2013-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

Event Description

At about 14 years 3 months after the primary, the patient came in reporting instability and the cause is unknown.The surgeon upsized the insert and the surgery was completed successfully.

• Brand Name: EVOLIS TIBIAL INSERT UC FLEX SIZE3 13 MM
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18795924
• MDR Text Key: 336396423
• Report Number: 3005180920-2024-00061
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081023
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 3046.0313
• Device Lot Number: 081379
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2008
• 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 Age: 61 YR
• Patient Sex: Female