MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE TOTAL KNEE SYSTEM; FIXED TIBIAL INSERT SIZE 3/12MM

Model Number	02.09.0312H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperextension (4523)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 6 february 2025: lot 2243839: (b)(4) items manufactured and released on 13/01/2023.Expiration date: 14/12/2027.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.Additional implants involved, batch review performed on 6 february 2025: gmk-hinge 02.09.2603r femoral component size 3 r (k130299) lot 2214183: (b)(4) items manufactured and released on 26/10/2022.Expiration date: 05/10/2027.No anomalies found related to the problem.To date, all items of the same lot have been sold with one similar reported event during the period of review.Gmk-hinge 02.09.4003r fixed tibial tray size 3 r (k130299) lot 2200960: (b)(4) items manufactured and released on 31/05/2022.Expiration date: 13/05/2027.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: almost 2 years after receiving a constrained total knee system as a primary implant, the patient is generally unhappy.The surgeon reports a 10° hyperextension that appears to be the main cause for the patient's complaint, according to our interpretation of the report.We have no information as to the preoperative condition of the patient.Receiving a hinge system in primary surgery means that there is a deficiency in the stabilizing mechanisms of the knee.Hyperextension is controlled mainly by the posterior capsule, and the absence or incompetence of the posterior chain can generate excessive loads on the polyethylene bushing that may reduce the longevity of the implant.On the other hand, it is also possible that the knee has residual laxity: if such laxity is significant, the capsule may not be in a position to exercise its role of controlling hyperextension.Hence, a possible action to help restore control of hyperextension could be increasing the thickness of the insert, if possible.This might be undertaken, if judged appropriate by the surgeon, together with a soft tissue reconstruction surgery, if required.The femoral component may have been implanted in a slightly flexum position, for unspecified reasons.In a constrained implant, a flexed position of the femoral component may imply higher loads on the pe bushing that stops hyperextension, because the prosthesis will be in a hyper-extended position when the angle between femur and tibia on the sagittal plane is actually 0°, so in full extension but not hyperextension.
Event or Problem Description
About 1 year and 9 months after the primary surgery (primary gmk-hinge), during a follow-up visit, x-rays were taken and a hyperextension of about 10 degrees was observed.The hyperextension affects the patient's gait pattern.
Additional Manufacturer Narrative
Additional information entered in the follow-up 1: r&d evaluation.R&d investigation: during a routine follow-up visit at almost 2 years from implantation of a gmk hinge knee prosthesis, the patient was noted to exhibit approximately 10° of knee hyperextension.This hyperextension has been observed to impact the patient's gait pattern.There is no reported pain or discomfort associated with the hyperextension at this time.X-rays show the implant is properly positioned; thus hyperextension is most likely attributable to insufficient knee stability.In gmk hinge systems, where natural ligaments are no longer present, joint stability relies predominantly on the appropriate tensioning of the posterior capsule and surrounding residual soft tissues.It remains uncertain whether the current instability is due to insufficient stabilization at the time of the primary procedure or if it has developed progressively over time due to soft tissue changes.In cases where the knee lacks proper stabilization, hyperextension may occur until it is mechanically limited by the mechanical stop of the implant.This condition is not anticipated in normal use of the device and may result in increased loads, potentially compromising implant longevity.To manage the hyperextension, one possible intervention could be to increase the thickness of the insert, if feasible.Alternatively, the use of a knee brace to limit hyperextension might be considered a non-surgical intervention.Conclusions: hyperextension is primarily regulated by the posterior capsule, and the absence or dysfunction of it can lead to excessive stress on the polyethylene insert, potentially compromising the longevity of the implant.Conversely, the knee may exhibit residual laxity; if this laxity is pronounced, the posterior capsule may be unable to effectively perform its role in controlling hyperextension.However, no definitive conclusion can be drawn for this specific case, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: GMK HINGE TOTAL KNEE SYSTEM
• Common Device Name: FIXED TIBIAL INSERT SIZE 3/12MM
• 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: 21525740
• Report Number: 3005180920-2025-00114
• Device Sequence Number: 9712989
• Product Code: KRO
• UDI-Device Identifier: 07630030825125
• UDI-Public: 07630030825125
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130299
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: 02.09.0312H
• Device Lot Number: 2243839
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female