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

Model Number 02.12.0410FL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/14/2022

Event Type  Injury  

Event Description

At 7 years and 1 month after the primary surgery, the revision surgery was performed due to unscrewing of the inlay locking screw.The surgeon removed loosened screw and revised the poly without inserting a new screw.The patient had an heavy fall at about 3 years ago.

Manufacturer Narrative

Batch review performed on 16 september 2022: lot 145468: (b)(4) items manufactured and released on 26-nov-2014.Expiration date: 2019-09-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medacta medical affairs director: 7 years after primary cemented tka the patient reports pain and the radiographic analysis shows the insert fixation screw lose near the joint space.The patient reported a traumatic event some time before, but it is unlikely that any relationship exists between fall and lose screw.The possibility of self-unscrewing has been demonstrated and reproduced in the laboratory when insufficient tightening torque was applied at primary surgery.Insufficient torque could therefore be considered the root cause for this adverse event, although it is possible that other undetermined factors may have played a role.The delay between surgery and self-unscrewing is normally much shorter, but it is well possible that the screw had been lose for some time.The torque-limiting screwdriver has been introduced after the index operation.If the surgeon, at revision surgery, assessed that no relevant damage to the metallic components had taken place, we should expect no further consequences.

Manufacturer Narrative

Visual inspection performed by r&d project manager: revision surgery of a gmk sphere insert due to loosening of the insert secure screw after 7 years from primary implantation.Visual inspection of the returned screw.The head and the threaded part of the screw look partially damaged.Threads have been plastically pressed once, lossened in the joint, were interposed between the femoral component and the tibial insert and underwent to the body load.The most likely cause of self unscrewing of the screw was insufficient tightening torque.Using a screwdriver provided with a torque limitation (ref.(b)(4)) would prevent this event: torque limiter screwdriver was not available at the time of the primary surgery but now is available and its use is now mandatory in case of usage of the insert secure screw.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L
• 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: 15572068
• MDR Text Key: 301504155
• Report Number: 3005180920-2022-00756
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030826535
• UDI-Public: 07630030826535
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 02/10/2023

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 Expiration Date: 09/30/2019
• Device Model Number: 02.12.0410FL
• Device Catalogue Number: 02.12.0410FL
• Device Lot Number: 145468
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/10/2022
• Supplement Dates Manufacturer Received: 09/12/2022
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2014
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White