GMK Hinge Total Knee SystemRecalls & reported problems across all models
Medacta International SA · 55 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 224
- Deaths reported
- 0
- Injuries reported
- 203
- Recalls
- 0
We found 55 models of GMK Hinge Total Knee System by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 224 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2017 and Aug 12, 2026 — classified as 203 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (76 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported GMK Hinge Total Knee System problems
Device problems
- Device Appears to Trigger Rejection76
- Appropriate Device Problem Term/Code Not Available34
- Adverse Event Without Identified Device or Use Problem28
- Break18
- Fracture13
- Loose or Intermittent Connection11
- Device Dislodged or Dislocated9
- Loosening of Implant Not Related to Bone-Ingrowth7
Patient problems
- Unspecified Infection62
- Medical device site infection61
- No Known Impact Or Consequence To Patient16
- Pain13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available11
- Insufficient Information9
- Bone Fracture(s)7
- Joint Disorder7
GMK Hinge Total Knee System models
55 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GMK Hinge Total Knee System 02.09.0312HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer16 reports
- GMK Hinge Total Knee System 02.09.0212HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer12 reports
- GMK Hinge Total Knee System 02.09.0214HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer12 reports
- GMK Hinge Total Knee System 02.09.0412HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer12 reports
- GMK Hinge Total Knee System 02.09.0314HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer11 reports
- GMK Hinge Total Knee System 02.09.0414HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer11 reports
- GMK Hinge Total Knee System 02.09.0417HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer9 reports
- GMK Hinge Total Knee System 02.09.0320HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer8 reports
- GMK Hinge Total Knee System 02.09.0514HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer8 reports
- GMK Hinge Total Knee System 02.09.0517HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer8 reports
- GMK Hinge Total Knee System 02.09.0317HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer6 reports
- GMK Hinge Total Knee System 02.09.2604LProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer6 reports
- GMK Hinge Total Knee System 02.09.2605RProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer6 reports
- GMK Hinge Total Knee System 02.09.2606RProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer6 reports
- GMK Hinge Total Knee System 02.09.0117HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer5 reports
- GMK Hinge Total Knee System 02.09.0217HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer5 reports
- GMK Hinge Total Knee System 02.09.0512HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer5 reports
- GMK Hinge Total Knee System 02.09.2603LProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer5 reports
- GMK Hinge Total Knee System 02.09.0423HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer4 reports
- GMK Hinge Total Knee System 02.09.2602RProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer4 reports
- GMK Hinge Total Knee System 02.09.4005RProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer4 reports
- GMK Hinge Total Knee System 02.09.0112HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 reports
- GMK Hinge Total Knee System 02.09.0326HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 reports
- GMK Hinge Total Knee System 02.09.0420HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 reports
- GMK Hinge Total Knee System 02.09.0520HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 reports
- GMK Hinge Total Knee System 02.09.2602LProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 reports
- GMK Hinge Total Knee System 02.09.2603RProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 reports
- GMK Hinge Total Knee System 02.09.4001RProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 reports
- GMK Hinge Total Knee System 02.09.4003LProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 reports
- GMK Hinge Total Knee System 02.09.0114HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- GMK Hinge Total Knee System 02.09.0120HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- GMK Hinge Total Knee System 02.09.0126HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- GMK Hinge Total Knee System 02.09.0220HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- GMK Hinge Total Knee System 02.09.0223HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- GMK Hinge Total Knee System 02.09.0523HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- GMK Hinge Total Knee System 02.09.0612HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- GMK Hinge Total Knee System 02.09.0614HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- GMK Hinge Total Knee System 02.09.2604RProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- GMK Hinge Total Knee System 02.09.4003RProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- GMK Hinge Total Knee System 02.09.TA310Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- GMK Hinge Total Knee System 02.09.0323HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GMK Hinge Total Knee System 02.09.0426HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GMK Hinge Total Knee System 02.09.0623HProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GMK Hinge Total Knee System 02.09.2601LProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GMK Hinge Total Knee System 02.09.2605LProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GMK Hinge Total Knee System 02.09.4002LProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GMK Hinge Total Knee System 02.09.4004LProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GMK Hinge Total Knee System 02.09.4004RProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GMK Hinge Total Knee System 02.09.4006LProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GMK Hinge Total Knee System 02.09.TA110Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GMK Hinge Total Knee System 02.09.TA210Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GMK Hinge Total Knee System 02.09.TA305Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GMK Hinge Total Knee System 02.09.TA405Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GMK Hinge Total Knee System 02.09.TA505Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GMK Hinge Total Knee System 02.09.TA510Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
Recent GMK Hinge Total Knee System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 12, 2026Device Appears to Trigger Rejection
Revision surgery due to infection after about 7 months from first revision surgery. The surgeon performed a washout and revised the 20mm - Size 4 GMK-Hinge insert to a same size insert. The patient ha primary surgery with competitor implants.
Patient problems: Medical device site infection
MAUDE report 50222759 ↗InjuryAug 3, 2026Device Appears to Trigger Rejection
Revision surgery due to infection after 21 days from primary. The surgeon performed a washout, removed all implants, and implanted a competitor femoral nail.
Patient problems: Medical device site infection
MAUDE report 50114133 ↗InjuryAug 3, 2026Device Appears to Trigger Rejection
Revision surgery after 5 days from the last surgery due to infection. The surgeon performed a washout and a second-stage poly swap to a poly of the same size. The surgery was completed successfully.
Patient problems: Medical device site infection
MAUDE report 50114120 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
The patient had primary left knee surgery with competitor products. On (b)(6) 2024, the patient was revised to Medacta GMK-Hinge implants. Presently, on (b)(6) 2026, the patient came in due to signs of infection and the pathogen is unknown. The surgeon performed a washout, removed all implants and placed a cemented antibiotic spacer with external fixation. The surgery was completed successfully.
Patient problems: Medical device site infection
MAUDE report 50005870 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Revision surgery after 1 year and 11 months from the Medacta primary due to infection. The surgeon revised the insert to the same size insert.
Patient problems: Medical device site infection
MAUDE report 50005842 ↗InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY AFTER 2 MONTHS FROM PRIMARY DUE TO INFECTION.. THE SURGEON PERFORMED A WASHOUT AND REVISED THE SIZE 2 - 12MM HINGE TIBIAL INSERT TO THE SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25632992 ↗InjuryJun 26, 2026Device Appears to Trigger Rejection
AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 14MM GMK-HINGE SIZE 1 INSERT TO A SAME SIZE INSERT, AND REVISED THE 14MM TINBN COATED POST EXTENSION TO A SAME SIZE EXTENSION. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25632984 ↗MalfunctionJun 24, 2026Adverse Event Without Identified Device or Use Problem
DURING SURGERY, AT THE BACK-TABLE ASSEMBLY OF THE GMK HINGE FEMORAL COMPONENT WITH THE OFFSET CONNECTOR, THE WHITE PLASTIC BUSHING WAS FOUND TO BE COVERING THE SCREW HOLE. THE SURGICAL TEAM ATTEMPTED TO LOOSEN AND DISENGAGE THE BUSHING, BUT IT COULD NOT BE RELEASED DESPITE CONSIDERABLE EFFORT. CONSEQUENTLY, THE OFFSET CONNECTION SCREW COULD NOT BE INSERTED. THE SURGEON CONSIDERED THE OFFSET CONNECTOR TAPER LOCK TO BE STABLE AND IMPLANTED THE FEMORAL COMPONENT WITHOUT THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25607357 ↗InjuryJun 9, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION AFTER 2 YEARS AND 6 MONTHS FROM THE PRIMARY DUE TO INFECTION, AND THE PATHOGEN RETURNED AS STAPHYLOCOCCUS AUREUS. THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE GMK-HINGE SIZE 5 - 20MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25442539 ↗InjuryJun 9, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 MONTH FROM FIRST REVISION SURGERY. THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR IMPLANTS AND WAS REVISED TO MEDACTA IMPLANTS ON (B)(6) 2026. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-HINGE SIZE 4 - 17MM INSERT TO A GMK-HINGE SIZE 3 - 12MM AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25442527 ↗InjuryMay 26, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION AFTER 20 DAYS FROM FIRST REVISION SURGERY (FRACTURED FEMUR MDR: (B)(4). THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY ON (B)(6) 2026. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-HINGE 14MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25275471 ↗InjuryMay 21, 2026Device Appears to Trigger Rejection
THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2023, THE PATIENT WAS REVISED TO MEDACTA GMK-HINGE IMPLANTS. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-HINGE TIBIAL INSERT SIZE 3 - 20MM TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25242297 ↗InjuryMay 13, 2026Fracture
REVISION SURGERY DUE TO A FRACTURED FEMUR AFTER ABOUT 2 MONTHS FROM PRIMARY AND THE CAUSE IS UNKNOWN. THE WAS NO INDICATION OF TRAUMA, BUT THE SURGEON DID NOTE POOR BONE QUALITY. THE SURGEON REVISED GMK-HINGE SIZE 5 FEMORAL COMPONENT TO A SAME SIZE FEMORAL COMPONENT AND REVISED THE GMK-HINGE 12MM INSERT TO A GMK-HINGE 14MM INSERT DUE TO LAXITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s); Joint Laxity
MAUDE report 25160348 ↗InjuryMay 13, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 YEAR AND 4 MONTHS FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL IMPLANTS TO ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25160341 ↗InjuryMay 12, 2026Device Appears to Trigger Rejection
AT ABOUT 1 YEAR AND 8 MONTHS FROM THE PRIMARY, THEPATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE SIZE4 - 17MM INSERT TO A SIZE4 - 20MM INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25148955 ↗
Other Medacta International SA products
- GMK Sphere Total Knee System209 models · 2,306 reports
- GMK Primary Total Knee System99 models · 876 reports
- Shoulder System63 models · 716 reports
- AMIStem H Femoral Stems20 models · 679 reports
- Mpact Acetabular System68 models · 609 reports
- Mectacer Biolox Delta Femoral Ball Head15 models · 551 reports
- Quadra H femoral stems32 models · 354 reports
- MectaLIF Anterior6 models · 4 reports · 6 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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