GMK Total Knee System 02.07.2803LRecalls & reported problems
Medacta International SA · Tibial tray fixed cemented #3 L TiNbN coated · Class 2 · Implant
All models of GMK Total Knee System (31)
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 07630030821806), received between Mar 31, 2023 and May 23, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Migration” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Migration1
- No Apparent Adverse Event1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bone Fracture(s)1
- Hypersensitivity/Allergic reaction1
- Loss of Range of Motion1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2024No Apparent Adverse Event; No Apparent Adverse Event
DURING THE PRIMARY KNEE SURGERY, A TIBIAL BONE FRACTURE OCCURRED WHILE IMPLANTING THE TIBIAL TRAY. IN ORDER TO COMPLETE THE CASE, THE SURGEON PREPARED THE BONE FOR A 11X65 TIBIAL STEM AND THEN REIMPLANTED TRAY WITH THE STEM ATTACHED. THE SURGEON ALSO ADDED TWO 4.0 CANCELLOUS SCREWS TO REPAIR THE FRACTURE SITE. THERE WAS NO DELAY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 19380483 ↗InjuryJul 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ABOUT 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT REPORTING DIFFICULTIES WITH RANGE OF MOTION. AN ALLERGIC RESPONSE IS SUSPECTED, BUT THE PATIENT DENIES ANY RASHES OR ITCHING IN THE AREA. THE SURGEON HAS NO PLANS TO REVISE THE PATIENT AT THIS TIME.
Patient problems: Hypersensitivity/Allergic reaction; Loss of Range of Motion
MAUDE report 17412889 ↗InjuryMar 31, 2023Migration; Migration
REVISION SURGERY PERFORMED AT ABOUT 1 MONTH AND 2 WEEKS AFTER PRIMARY DUE TO CEMENTED TIBIAL TRAY SUBSIDENCE. THE SURGEON REVISED SUCCESSFULLY THE FEMORAL AND TIBIAL COMPONENT AND THE INSERT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16655171 ↗
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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