GMK Revision Total Knee System 02.07.2402LRecalls & reported problems
Medacta International SA · Femur revision PS cemented left, size 2 · Class 2 · Implant
All models of GMK Revision Total Knee System (71)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030821387), received between Apr 2, 2019 and Apr 3, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant1
- Implant Pain1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMORAL COMPONENT AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 6 MONTHS POST PRIMARY, THE SURGEON REVISED THE INSERT AND FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT ORIGINALLY HAD COMPETITOR COMPONENTS AND THEN WAS IMPLANTED WITH MEDACTA REVISION SYSTEM.
Patient problems: Implant Pain
MAUDE report 16664473 ↗InjuryMay 31, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AT 5 YEARS 8 MONTHS AFTER THE PRIMARY, REVISION SURGERY FOLLOWING THE LOOSENING OF THE FEMORAL COMPONENT. THE SURGEON REVISED SUCCESSFULLY THE FEMORAL COMPONENT AND THE INLAY.
Patient problems: Failure of Implant
MAUDE report 14547141 ↗InjuryApr 2, 2019Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN, 2 YEARS AND 4 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION. THE SURGEON EXPLANTED ALL IMPLANTS, PERFORMED A WASHOUT AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 8473645 ↗
Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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