MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L

Model Number	02.07.1204L
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14-mar-2025 lot 2002933: (b)(4) items manufactured and released on 19-may-2020.Expiration date: 05-may-2025.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.Other devices involved: gmk-sphere 02.12.0410crl tibial insert fixed sphere cr size 4/10 mm l (k181635) lot 2003196: (b)(4) items manufactured and released on 30-jul-2020.Expiration date: 19-jul-2025.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.Analysis performed by r&d manager: revision surgery of a gmk sphere implant after 4 years and 4 months from primary implantation due to aseptic loosening of femoral component and tibia baseplate.The investigation is based on the picture of the explanted tibial tray, in which no residual cement can be noted on the distal surface of the tibial baseplate.No anomalies can be noted on the tibial baseplate implant.The event of a poor interdigitation between cement and implant for both tibial and femoral components can be related to multiple factors, most likely not implant related (such as cementation process, temperature, cementation timing, presence of fluids on the surfaces of cement interface).From the analysis, there is no evidence to suspect that the event is related to faulty devices.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
At about 4 years and 4 months after primary, the patient came in reporting instability.The surgeon decided to revise the patient, and during the revision it was observed that the primary implants were all loose with little to no cement adherence.The surgeon revised all implants to gmk-revision.The surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L
• 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: 21772690
• Report Number: 3005180920-2025-00246
• Device Sequence Number: 12784117
• Product Code: JWH
• UDI-Device Identifier: 07630030819902
• UDI-Public: 07630030819902
• 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: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

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 Expiration Date: 05/05/2025
• Device Model Number: 02.07.1204L
• Device Lot Number: 2002933
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2020
• 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