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

Catalog Number 02.12.0410FR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Laxity (4526)

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 20-dec-2023: lot 1810394: (b)(4) items manufactured and released on 14-mar-2019.Expiration date: 2024-03-03.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported case during the period of the review.

Event Description

At about 4 years and 10 months after primary, the patient was revised because of instability.The liner was changed with a thicker one (10mm to 14mm) and patellar bone has been resurfaced.The surgery was completed successfully.

Manufacturer Narrative

Clinical evaluation performed by medical affairs director on (b)(6) 2024: 5 years after primary cemented tka, instability develops and probably also (unreported) anterior knee pain.The surgeon proceeds then to secondary resurfacing of patella and to augment the joint stability with a thicker insert.Both causes (secondary anterior knee pain and secondary ligament laxity) are normal disease progression and the reoperation was therefore not caused by a failure of the former treatment.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18386908
• MDR Text Key: 331289630
• Report Number: 3005180920-2023-01027
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030826542
• UDI-Public: 07630030826542
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K121416
• 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,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2024
• Device Catalogue Number: 02.12.0410FR
• Device Lot Number: 1810394
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2019
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 81 KG