MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R

Model Number	02.07.1202R
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to metallosis with loosening of the knee system at about 2 years.The surgeon revised all system with competitors.
Additional Manufacturer Narrative
Batch review performed on 19 may 2025: lot 2218236: (b)(4) items manufactured and released on 17-nov-2022.Expiration date: 2027-11-06.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Visual inspection performed by r&d project manager: a revision surgery was performed on a total knee arthroplasty (tka) involving a gmk sphere uncemented femoral component and a cemented tibial tray due to aseptic loosening and metallosis, occurring two years after the primary implantation.Visual inspection of the explanted femoral component returned for investigation indicates a complete lack of osteointegration between the component and the patient's bone.This is evidenced by the absence of residual bone on the porous coated surface of the implant.Additionally, a localized loss of cementless coating was observed in the box region and on the distal inner area of the femoral component.A plausible explanation for this coating detachment is micromotion resulting from failed osteointegration and lack of secondary fixation.The associated shear stress caused by micromotion may have caused the coating to delaminate, as confirmed by the smooth areas where coating is missing.The coating remains present and intact over the majority of the inner surfaces of the femoral component.The lack of osteointegration can be attributed to several patient- or surgery-related factors, such as implant positioning, bone quality, or loading conditions.There is no clear evidence suggesting that the failure is due to a manufacturing or design defect.Signs of third body wear were identified on the articular surface of the femoral component.This is likely associated with coating debris generated from the detached porous layer, which may have led to particle-induced metallosis and the associated clinical symptoms.The cemented tibial tray and tibial insert screw were also returned and subjected to visual inspection.Residual bone cement was observed on the distal surface of the tibial baseplate, indicating that the cementation process had been performed.No abnormalities or mechanical damage were noted on either the tibial baseplate or the screw.No diagnostic imaging (e.G., x-ray, ct, or mri) was provided with the complaint documentation to support the clinical diagnosis of component loosening.Based on the visual inspection and available information, there is no evidence that the event is related to a device defect.The failure appears to be due to insufficient osteointegration of the femoral component, likely driven by patient-specific or surgical factors, which led to micromotion, partial coating delamination, third body wear, and subsequent metallosis.Additional implants revised, batch review performed on 19 may 2025: gmk-sphere 02.12.0210fr tibial insert fixed sphere flex size 2/10 mm r (k121416) lot 2240058: (b)(4) items manufactured and released on 17-nov-2022.Expiration date: 2027-10-30.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.Gmk-sphere 02.12.1022r femoral component sphere cementless size 2+ r (not registered in jp) lot 2212947: (b)(4) items manufactured and released on 28-oct-2022.Expiration date: 2027-10-16.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.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R
• 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: 22193763
• Report Number: 3005180920-2025-00529
• Device Sequence Number: 18469203
• Product Code: JWH
• UDI-Device Identifier: 07630030826146
• UDI-Public: 07630030826146
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2025

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: 02.07.1202R
• Device Lot Number: 2218236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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: 79 YR
• Patient Sex: Female