MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; FEMORAL COMPONENT SPHERE TINBN COATED SIZE 6 R

Model Number	02.12.0706R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 03 june 2026: gmk-sphere 02.12.0706r femoral component sphere tinbn coated size 6 r (k202684) lot: 2303670: (b)(4) items manufactured and released on 21-jun-2023.Expiration date: 03-jun-2028.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 02.12.0612fr gmk-sphere tibial insert - flex s6r - 12 mm (k121416) lot: 2204113: (b)(4) items manufactured and released on 02-jun-2022.Expiration date: 11-apr-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.Gmk-sphere 02.07.2806r fixed tibial tray size 6 r - tinbn coating (k202684) lot: 2247571: (b)(4) items manufactured and released on 06-jun-2023.Expiration date: 18-may-2028.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 02.07.0035rp patella resurfacing s.3 (new generation) (k090988) lot: 2514296: (b)(4) items manufactured and released on 30-jun-2025.Expiration date: 15-jun-2030.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 the medacta medical manager: this complaint describes revision surgery of a cemented gmk-sphere total knee arthroplasty approximately 6 months after primary implantation.The reported reason for revision was infection.No x-rays are available for radiographic assessment.Based on the reported photographic evidence, no residual cement appears to be present on the implanted components, a finding suggestive of implant-cement interface debonding.The reason for this debonding is not known.Infection may have played a role in the loss of fixation, but cementation-related factors during the primary surgery may also have contributed, including cement handling, timing, temperature, or other intraoperative variables.Based on the available information, no definitive root cause can be established.Investigation performed by medacta knee r&d project manager: this complaint describes revision surgery of a cemented gmk-sphere total knee arthroplasty approximately 6 months after primary implantation.The reported reason for revision was infection.Based on the available pictures, the femoral, tibial, and patellar components show a lack of residual cement within the cement pockets.On the femoral component, it is not possible to clearly determine whether some cement remains adhered to the anterior side of the component.No definitive conclusion regarding the quality of cement fixation or the condition of the implant-cement and cement-bone interfaces can be established from the available photographic documentation alone.Infection may compromise the local biological environment and can contribute to pain, inflammation, implant instability, and the need for revision.Based on the available information, the reported revision appears consistent with an infection-related failure.Based on the available evidence, no confirmed device-related defect, cementation defect, or implant-cement interface issue can be identified as the initiating cause of the event.No further conclusion regarding the root cause can be drawn from the photographic documentation alone.Root cause:based on the information available, the reported revision appears consistent with an infection-related failure approximately six months after primary implantation.Infection is a known possible post-operative complication and may compromise the local biological environment, potentially contributing to pain, inflammation, implant instability, loss of fixation, and the need for revision.The absence of residual cement on the explanted components, as reported by the branch, is suggestive of implant-cement interface debonding; however, no definitive conclusion regarding the quality of cement fixation or the initiating cause of the event can be established from the available information.The device history record reviews for the involved lots did not indicate any potentially related manufacturing issue, and no confirmed device-related defect, cementation defect, or implant-cement interface issue was identified as the initiating cause.
Event or Problem Description
Revision surgery due to infection at about 6 months from primary.Pathogen unknown, all devices revised successfully and antibiotic spacer implanted.It has reported no cement found on the explants; this is commented in the complaint investigation.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: FEMORAL COMPONENT SPHERE TINBN COATED SIZE 6 R
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25607351
• Report Number: 3005180920-2026-00577
• Device Sequence Number: 5405865
• Product Code: JWH
• UDI-Device Identifier: 07630040711470
• UDI-Public: 07630040711470
• Combination Product (Y/N): N
• PMA/510(K) Number: K202684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: 02.12.0706R
• Device Lot Number: 2303670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White