MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; GMK SPHERIKA FEMORAL COMPONENT S3+R CEMENTED

Model Number	02.12.KA13R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Pain (1994); Medical device site infection (4845)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent total knee arthroplasty, with subsequent postoperative healing difficulties.At the most recent follow-up, the patient reported worsening pain associated with internal instability, along with marked pain in the tibial metaphysis and the femoropatellar joint.At 11 months from the primary, revision surgery was performed implanting a semi-constrained knee prosthesis.Intraoperative samples confirmed the presence of chronic periprosthetic infection.
Additional Manufacturer Narrative
Batch review performed on 06 aug 2025.Gmk-spherika 02.12.Ka13r gmk spherika femoral component s3+r cemented (k211004) lot.2408292: (b)(4) items manufactured and released on 08-jul-2024.Expiration date: 2029-06-19.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 devices also revised: gmk-spherika 02.12.0212fr gmk-sphere tibial insert - flex s2r - 12 mm (k121416) lot.2338835: (b)(4) items manufactured and released on 05-oct-2023.Expiration date: 2028-09-23.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.Gmk-spherika 02.12.3d02r gmk 3dmetal tibial tray size 2r (k221850) lot.2308265: (b)(4) items manufactured and released on 10-oct-2023.Expiration date: 2028-09-14.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.Conclusions: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Additional Manufacturer Narrative
Initial emdr was submitted on the same day when the involved devices were received by the manufacturer and the analysis was yet to be performed.Visual inspection performed by r&d department: the explanted 3dm tibial baseplate and cementless femoral component were visually inspected upon return for investigation.Despite the presence of infection, both components appeared to habe been well integrated, with residual bone observed within the porous structure designed to enable bone ingrowth.The revision surgery was necessitated by infection.Based on the visual inspection, there is no evidence that the event was related to a defective device.Updated fields d9.H11.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: GMK SPHERIKA FEMORAL COMPONENT S3+R CEMENTED
• 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: 22894250
• Report Number: 3005180920-2025-00833
• Device Sequence Number: 8958024
• Product Code: JWH
• UDI-Device Identifier: 07630345716224
• UDI-Public: 07630345716224
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K211004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 09/04/2025

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.KA13R
• Device Lot Number: 2408292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 73 KG