GMKRecalls & reported problems across all models
Medacta International SA · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls
- 0
We found 4 models of GMK by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Sep 19, 2022 and Jun 26, 2026 — classified as 21 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 problems
Device problems
- Adverse Event Without Identified Device or Use Problem11
- Device Appears to Trigger Rejection5
- Device Dislodged or Dislocated4
- Loosening of Implant Not Related to Bone-Ingrowth1
- Migration1
Patient problems
- Implant Pain5
- Medical device site infection5
- Joint Dislocation3
- Joint Laxity3
- Pain3
- Damage to Ligament(s)1
- Insufficient Information1
- Unspecified Tissue Injury1
GMK models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GMK 02.12.E001RPProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer10 reports
- GMK 02.12.E002RPProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- GMK 02.12.E003RPProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer4 reports
- GMK 02.12.E004RPProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
Recent GMK adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. ADDITIONALLY, THE SURGEON OBSERVED A PATELLA BONE FRAGMENT FLOATING IN THE KNEE WHICH WAS REMOVED. THE CAUSE IS UNKNOWN. THERE WAS NO INDICATIONS OF TRAUMA. AT ABOUT 1 YEAR AND 5 MONTHS POST PRIMARY THE SURGEON REVISED THE S4 RESURFACING PATELLA TO A S3 PATELLA, AND REVISED THE 11MM FLEX 5L INSERT TO A 13MM FLEX 5L INSERT.
Patient problems: Joint Laxity
MAUDE report 25632993 ↗InjuryApr 30, 2026Device Appears to Trigger Rejection
THE PATIENT HAD A KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 3 MONTHS FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE PATELLA AND FEMORAL COMPONENT TO A SAME SIZE PATELLA AND FEMORAL COMPONENT. THE SURGEON REVISED THE 10MM INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25039770 ↗InjuryFeb 20, 2026Device Dislodged or Dislocated
AT ABOUT 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE PAIN AS A RESULT OF CHRONIC DISLOCATION OF THE PATELLA AND THE CAUSE IS UNKNOWN. PREVIOUS DISLOCATIONS CORRECTED WITH REDUCTION. THE SURGEON REVISED THE FEMUR, TIBIAL COMPONENT, AND INSERT FROM GMK-SPHERIKA TO GMK-REVISION TO ADDRESS THE DISLOCATIONS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 24399531 ↗InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FIVE MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH ANTERIOR KNEE PAIN OF UNKNOWN ORIGIN. THE SURGEON REPORTED THAT THE PATIENT HAD A LOW PAIN TOLERANCE AND QUESTIONED WHETHER IT WAS A TRUE DISLOCATION, SUGGESTING THAT IT MIGHT HAVE BEEN A PATELLAR TILT, A MORE COMMON POSTOPERATIVE OCCURRENCE IN TKA CASES WHEN THE PATELLA HAS BEEN RESURFACED. A LATERAL RELEASE OF THE PATELLAR TENDON WAS PERFORMED, FOLLOWED BY A WASHOUT AND LINER REVISION AS PER STANDARD PROCEDURE. THE SURGERY WAS SUCCESSFULLY COMPLETED.
Patient problems: Implant Pain
MAUDE report 23583094 ↗InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
11 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH PATELLAR TRACKING ISSUES OF UNKNOWN CAUSE. THE SURGEON REVISED THE PATELLAR COMPONENT AND REPLACED THE LINER PER STANDARD PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 23510645 ↗InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT 1 YEAR AND 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON DETERMINED THE PATELLA WAS MISTRACKED. THE SURGEON REVISED THE PATELLA FROM AN S1 TO AN S3. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 23347368 ↗InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT ABOUT 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN PATELLA TENDON AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATELLA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Damage to Ligament(s)
MAUDE report 23070843 ↗InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED PAIN DUE TO PATELLA TRACKING ISSUES OF UNKNOWN CAUSE. THE SURGEON REVISED THE FEMUR AND INSERT AND ADDED A LATERAL FEMORAL AUGMENT TO SHIFT THE KNEE INTO MORE VARUS, STABILIZING THE PATELLA.THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 22902798 ↗InjuryJul 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 2 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE PATIENT UNDERWENT REMOVAL OF THE ANTIBIOTIC SPACERS ON (B)(6) 2025, FOLLOWED BY IMPLANTATION OF THE PERMANENT HARDWARE THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 22664405 ↗InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN, AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE PATELLA TO A THINNER PATELLA AND REMOVED MORE BONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 22577498 ↗InjuryMay 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 1 YEAR AND 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 22078238 ↗InjuryMar 25, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATED PATELLA IMPLANT AND KNEE INSTABILITY. THE SURGEON REVISED THE 17MM POLY WITH A 20MM POLY AND PERFORMED A LATERAL RELEASE AND VMO ADVANCEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 21687575 ↗InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT 1 YEAR AND 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATELLA AND UPSIZED THE POLY (FROM 12 TO 17 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Laxity
MAUDE report 20680970 ↗InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT ABOUT 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A RUPTURED PATELLA TENDON AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED PATELLA TENDON REPAIR AND REVISED ALL COMPONENTS TO HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Tissue Injury
MAUDE report 19749118 ↗InjuryJul 1, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER AND PATELLA IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 19641740 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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