MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY FIXED CEMENTED SIZE 6 R

Model Number	02.07.1206R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision due to tibial tray loosening about 8 years and 6 months after primary.No loosening of the femoral component.No infection.Explantation of the tibial tray and insert.Reimplantation of a gmk-revision tibial tray with wedges, offset and extension stem.
Additional Manufacturer Narrative
Batch review performed on 12 may 2026 lot 171157: (b)(4) items manufactured and released on 19-july-2017.Expiration date: 2022-07-04.No anomalies found related to the problem.To date, 30 items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation: a revision surgery was performed approximately 8.5 years after implantation of a tka due to loosening of the tibial component.In the available radiographic images, the tibial tray appears medially shifted.This finding, together with the bone irregularities visible at both the medial and lateral margins of the tibial plateau, may be consistent with component mobilization and even possible subsidence.In addition, radiolucent areas are appreciable around the tibial component, particularly on the lateral projection, suggesting loss of fixation.Aseptic loosening is a well-documented adverse event following primary tka and is described in the literature as a multifactorial complication with often unclear etiology.Possible contributing factors may include bone quality, mechanical loading, implant positioning, fixation quality, or patient-related variables.Based on the available information, the precise root cause of this failure cannot be definitively determined.At present, there is no evidence to suggest a defective or malfunctioning implant.Root cause: aseptic loosening is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIXED CEMENTED SIZE 6 R
• 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: 25268617
• Report Number: 3005180920-2026-00488
• Device Sequence Number: 15749411
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2026

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: 07/04/2022
• Device Model Number: 02.07.1206R
• Device Lot Number: 171157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2017
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 110 KG