MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK IMPLANTS; TIBIAL TRAY FIX CEMENTED S.2R

Model Number	02.07.1202R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 3 november 2025: gmk-sphere 02.07.1202r tibial tray fix cemented s.2r (k090988) lot 1901597: (b)(4) items manufactured and released on 17-jul-2019.Expiration date: 2024-jul-03.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0023r gmk-sphere femoral component cemented - 3+r (k140826) lot 1901886: (b)(4) items manufactured and released on 17-jun-2019.Expiration date: 2024-jun-04.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
The patient had pain due to a loose tibia and femur implants.At about 6 years post primary the surgeon revised the tibia, insert, and femur.The surgery was completed successfully.Lack of adherence to cement found.Non medacta cement was used during primary.

• Brand Name: GMK IMPLANTS
• Common Device Name: TIBIAL TRAY FIX CEMENTED S.2R
• 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: 23583097
• Report Number: 3005180920-2025-01117
• Device Sequence Number: 9578416
• Product Code: JWH
• UDI-Device Identifier: 07630030819872
• UDI-Public: 07630030819872
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• 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): 11/18/2025

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 Expiration Date: 07/03/2024
• Device Model Number: 02.07.1202R
• Device Lot Number: 1901597
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2019
• 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: Female