MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY FIX CEMENTED S.6R

Model Number	02.07.1206R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Implant Pain (4561); Aseptic loosening (4883)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 may 2025 gmk-sphere 02.07.1206r tibial tray fix cemented s.6r (k090988) lot 168526: (b)(4) items manufactured and released on 05-apr-2017.Expiration date: 26-mar-2022.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with two other similar reported events since the batch release.
Event or Problem Description
At about 8 years and 6 months from primary, the patient came in presenting pain due to loosening of the tibial implant.The surgeon elected to remove all medacta products and revise the patient with competitor implants.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIX CEMENTED S.6R
• 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: 25328460
• Report Number: 3005180920-2026-00514
• Device Sequence Number: 9805856
• Product Code: JWH
• UDI-Device Identifier: 07630030819957
• UDI-Public: 07630030819957
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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 Expiration Date: 03/26/2022
• Device Model Number: 02.07.1206R
• Device Lot Number: 168526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• 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 Sex: Unknown