MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; KNEE TIBIAL INSERT E-CROSS

Model Number	02.12.E0414FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 december 2024: lot 2119153: (b)(4) items manufactured and released on 07-march-2022.Expiration date: 2027-02-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.The developmental instability is a rather commonly described possible complication following tka, because soft tissue may stretch and provide insufficient stability.It is therefore common practice to resort to a thicker insert and recreate soft tissue tension.
Event or Problem Description
At about 1 year 9 months after the primary, the patient came in for anterior knee pain around the patella and joint instability.Post op imaging has confirmed that the base plate and femur are well fixed and the surgeon wants to replace the 14mm insert with a 15.5mm.The revision surgery is not yet planned as a compassionate use submission is on-going (it will not start until (b)(6) 2024).
Additional Manufacturer Narrative
Updated event description- at about 1 year 9 months after the primary, the patient came in for anterior knee pain around the patella and joint instability.Post op imaging has confirmed that the base plate and femur are well fixed and the surgeon wants to replace the 14mm insert with a 15.5mm.The revision surgery is not yet planned as a compassionate use submission is on-going (it will not start until january).No more info available to date.X-rays received on 21 february 2025.Clinical evaluation performed by medacta medical affairs manager: 2 years after cemented primary tka in a young but severely overweight patient, the laxity of the joint progresses and the patient feels pain and instability.The surgeon decides to replace the insert with a thicker one.Progressive ligament laxity is a known possible evolution after tka and it is not due or related to the devices formerly implanted.In this case, the surgeon assessed that the metal components are still well fixed, so the plan is to replace the insert only in order to give a size of the implant that is adapted to the evolved condition.The developmental instability is a rather commonly described possible complication following tka, because soft tissue may stretch and provide insufficient stability.It is therefore common practice to resort to a thicker insert and recreate soft tissue tension.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: KNEE TIBIAL INSERT E-CROSS
• 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: 21026665
• Report Number: 3005180920-2024-01145
• Device Sequence Number: 9106959
• Product Code: JWH
• UDI-Device Identifier: 07630971261914
• UDI-Public: 07630971261914
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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 Model Number: 02.12.E0414FL
• Device Lot Number: 2119153
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2022
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 129 KG