MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L E-CROSS; KNEE TIBIAL INSERT

Catalog Number 02.12.E0411FL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Laxity (4526)

Event Date 03/18/2024

Event Type  Injury  

Event Description

Revision surgery was performed about 3 months after the primary surgery due to the patient's natural patella shifting laterally.The surgeon resurfaced the natural patella and upsized the poly to address minor instability.The cause of the instability is unknown.

Manufacturer Narrative

Batch review performed on 10 april 2024: lot 2317660: (b)(4) items manufactured and released on 08-aug-2023.Expiration date: 2028-07-25.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.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L E-CROSS
• 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: 19085956
• MDR Text Key: 339877007
• Report Number: 3005180920-2024-00235
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630971261792
• UDI-Public: 07630971261792
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202022
• 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: 04/11/2024

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 Catalogue Number: 02.12.E0411FL
• Device Lot Number: 2317660
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2023
• 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