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

Model Number	02.12.0114FR
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 10 months after the primary surgery, revision was performed due to knee snapping during walking.No pain was reported by the patient.The surgery was completed successfully revising the tibial insert (14mm) with an insert of the same thickness (14mm), restoring the stability of the knee.
Additional Manufacturer Narrative
Batch review performed on 22-dec-2022.Lot: 2002794: (b)(4) items manufactured and released on 23-jun-2020.Expiration date: 2025-06-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
Additional Manufacturer Narrative
Reference of the product corrected, lot not changed.Clinical evaluation performed by medical affairs department.Almost 2 years after the primary tkr, the joint in unstable and the patient reports a snap feeling when walking - no pain.The surgeon replaces the insert to a thicker one and the problem seems to be solved.The root cause should therefore be defined as secondary progressive instability due to ligament laxity.This is a possible developmental complication after knee replacements, broadly described in literature.It is not due to a faulty device.Visual inspection performed by r&d project manager revision surgery of a gmk sphere implant after almost 2 years of primary implantation due to snapping of the knee while walking.During the revision surgery the tibial insert has been replaced with a thicker one.From visual inspection of the explanted insert, no anomalies can be noted.From event description and visual inspection we guess the cause of the pain and the revision was instability.From visual inspection, there is no evidence that the event is related to a faulty device.
Event or Problem Description
At about 1 year and 10 months after the primary surgery, revision was performed due to knee snapping during walking.No pain was reported by the patient.The surgery was completed successfully revising the tibial insert (11mm) with a thicker one (14mm), restoring the stability of the knee.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM
• Common Device Name: 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: 16032554
• Report Number: 3005180920-2022-00968
• Device Sequence Number: 17940572
• Product Code: JWH
• UDI-Device Identifier: 07630030862625
• UDI-Public: 07630030862625
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2025
• Device Model Number: 02.12.0114FR
• Device Catalogue Number: 02.12.0411FR
• Device Lot Number: 2002794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 100 KG