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

Model Number	02.12.E0310FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 oct 2024: lot 2249822: (b)(4) items manufactured and released on 17-apr-2023.Expiration date: 2028- 03-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs director: after implantation of a cemented tka bilaterally on an overweight lady, the left knee shows suboptimal kinematics, with the tibia shifting backwards before the actual flexion starts.This may be due to suboptimal position of the components, with the tibial plateau too advanced and the medial distal femoral condyle resting on the posterior lip of the tibial insert.The tibia may have an excessive internal rotation and perhaps a slight anterior slope and this may contribute to the problem being perceived by the patient.It is also possible that the varus/valgus alignment between femur and tibia is suboptimal when the femur is lying correctly on the center of the concave sphere in the insert.We do not think that this problem is related to malfunctioning or defective device.Preliminary investigation performed by r&d project manager: complaint for a patient treated with a gmk sphere implant and showing tibial posterior movement during kneeling (at about 90° of flexion) when the harmstring is activated.In all the other daily life activities the knee is stable.Looking at the video showing the behaviour of the knee during the activation of the kneeling phase, we can see the posterior translation of the tibia.This is likely related to a loose medial collateral ligament in flexion that could lead instability, particularly in activity when the body load is not applied.There is no evidence that the event is related to a faulty device.Additional items involved in the event, batch review performed on 01 oct 2024: gmk-sphere femoral component sphere cemented size 3+ r (k140826) lot 2308890: (b)(4) items manufactured and released on 12-jul-2023.Expiration date: 2028-06-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere tibial tray fixed cemented size t4i3 r (k121416) lot 2304555: (b)(4) items manufactured and released on 09-aug-2023.Expiration date: 2028-07-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
During kneeling movements approaching 90º of flexion, an abnormal posterior translation of the tibia is observed when the hamstrings are activated.Following this translation, the range of motion (rom) returns to normal without any further abnormal movement.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT FIXED SPHERE
• 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: 20464712
• Report Number: 3005180920-2024-00847
• Device Sequence Number: 20762941
• Product Code: JWH
• UDI-Device Identifier: 07630971261525
• UDI-Public: 07630971261525
• Combination Product (Y/N): N
• Initial Reporter Country: CJ
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 02.12.E0310FR
• Device Lot Number: 2249822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2023
• 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
• Patient Sex: Female