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

Model Number	02.07.1204R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 march 2025.(b)(4) items manufactured and released on 30-apr-2024.Expiration date: 2029-04-17.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.Clinical evaluation performed by clinical affairs department: 8 months after primary cemented tka the tibial component becomes loose.The images supplied do not allow us to judge the position of the tibial baseplate, which has a significant angle to the tibial axis and looks slightly undersized, but we cannot judge if any of these two conditions may have contributed to the loosening.Therefore the real cause of the failure cannot be determined with the information at hand.At least preop radiographs, preferably long-leg, would be required to continue the investigation.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 investigation does not indicate any potential manufacturing related issue.
Event or Problem Description
Revision surgery at about 8 months post primary.The patient reported laxity and the joint had liquid effusion.No implant loosening found during the visit.Loosening of the tibial component found during the revision.No infection reported.Tibial components revised successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4
• 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: 21705293
• Report Number: 3005180920-2025-00203
• Device Sequence Number: 15985335
• Product Code: JWH
• UDI-Device Identifier: 07630030819919
• UDI-Public: 07630030819919
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/27/2025

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: 02.07.1204R
• Device Lot Number: 2348234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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: 57 YR
• Patient Sex: Unknown
• Patient Weight: 95 KG