MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY FIX CEMENTED S.1R

Model Number	02.07.1201R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 may 2025.Lot 147885d: (b)(4) item manufactured and released on 22-05-2022.Expiration date: 2027-05-02.No anomalies found related to the problem.Clinical evaluation: 2 years and 7 months after primary cemented tkr, the tibia baseplate is found mobilized and a partial substitution is carried out.The images supplied suggest that the original tibial tray may have been slightly undersized and this, in a heavy patient, may have contributed to an early subsidence, but of course many other factors may have also influenced.Aseptic loosening is a possible adverse event following tka and overweight patients are at higher risk, as specified in the device instructions.Visual inspection: revision surgery of a gmk sphere implant after 2 years and 7 months from primary implantation due to aseptic loosening of the tibial baseplate.The explanted tibial baseplate was returned for investigation.Visual inspection revealed the absence of residual cement on the distal surface of the implant.No macroscopic anomalies or manufacturing defects were observed on the tibial baseplate.The lack of cement interdigitation on the implant surface may be attributed to multiple factors, most likely not implant related, including but not limited to: cementing technique, curing temperature, timing of application, or the presence of fluids (e.G.Blood or lavage solution) at the cement-implant interface during fixation.Explanted tibial insert and fixation screw were also returned and subjected to visual inspection.No abnormalities or mechanical damage were noted on either the tibial insert or the screw.Based on the visual inspection, there is no evidence to suggest that the event was caused by a faulty device.
Event or Problem Description
Revision for tibial tray fixed cemented loosening at about 2 years and 7 months post primary.Tibial tray revised successfully.
Additional Manufacturer Narrative
During a check, an error was noted inside the emdr form sent.The stem was not revised, as it was found well fixed.Field d-6b should be empty.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIX CEMENTED S.1R
• 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: 22140919
• Report Number: 3005180920-2025-00480
• Device Sequence Number: 20891263
• Product Code: JWH
• UDI-Device Identifier: 07630030819858
• UDI-Public: 07630030819858
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/31/2025

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: 02.07.1201R
• Device Lot Number: 147885D
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2022
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White