GMK Primary Total Knee SystemRecalls & reported problems across all models
Medacta International SA · 99 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 876
- Deaths reported
- 0
- Injuries reported
- 861
- Recalls
- 0
We found 99 models of GMK Primary Total Knee System by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 876 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2017 and Aug 13, 2026 — classified as 861 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (183 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 Primary Total Knee System problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth183
- Appropriate Device Problem Term/Code Not Available173
- Adverse Event Without Identified Device or Use Problem142
- Device Appears to Trigger Rejection104
- Loose or Intermittent Connection89
- Unstable61
- Device Dislodged or Dislocated30
- Migration23
Patient problems
- Pain157
- Unspecified Infection142
- Joint Disorder122
- Joint Laxity94
- Medical device site infection77
- Implant Pain46
- Insufficient Information43
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available31
GMK Primary Total Knee System models
99 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GMK Primary Total Knee System 02.07.1204RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer65 reports
- GMK Primary Total Knee System 02.07.1202RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer61 reports
- GMK Primary Total Knee System 02.07.1205RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer61 reports
- GMK Primary Total Knee System 02.07.1204LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer59 reports
- GMK Primary Total Knee System 02.07.1205LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer54 reports
- GMK Primary Total Knee System 02.07.1203LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer53 reports
- GMK Primary Total Knee System 02.07.1203RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer53 reports
- GMK Primary Total Knee System 02.07.1202LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer49 reports
- GMK Primary Total Knee System 02.07.0034RPProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer42 reports
- GMK Primary Total Knee System 02.07.0035RPProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer36 reports
- GMK Primary Total Knee System 02.07.0310PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer18 reports
- GMK Primary Total Knee System 02.07.0036RPProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer15 reports
- GMK Primary Total Knee System 02.07.1206RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer15 reports
- GMK Primary Total Knee System 02.07.0033RPProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer14 reports
- GMK Primary Total Knee System 02.07.0410SFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer14 reports
- GMK Primary Total Knee System 02.07.0410FUCProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer12 reports
- GMK Primary Total Knee System 02.07.0412FUCProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer11 reports
- GMK Primary Total Knee System 02.07.0412PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer10 reports
- GMK Primary Total Knee System 02.07.0312PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer9 reports
- GMK Primary Total Knee System 02.07.0510SFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer9 reports
- GMK Primary Total Knee System 02.07.0214FUCProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer8 reports
- GMK Primary Total Knee System 02.07.0212PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer7 reports
- GMK Primary Total Knee System 02.07.0414PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer7 reports
- GMK Primary Total Knee System 02.07.2004LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer7 reports
- GMK Primary Total Knee System 02.07.0310FUCProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Primary Total Knee System 02.07.0312FUCProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Primary Total Knee System 02.07.0312SFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Primary Total Knee System 02.07.0314FUCProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Primary Total Knee System 02.07.0314PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Primary Total Knee System 02.07.0410PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Primary Total Knee System 02.07.0510FUCProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Primary Total Knee System 02.07.0512FUCProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Primary Total Knee System 02.07.0512PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Primary Total Knee System 02.07.1201LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Primary Total Knee System 02.07.0212FUCProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- GMK Primary Total Knee System 02.07.0510PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- GMK Primary Total Knee System 02.07.1201RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- GMK Primary Total Knee System 02.07.1206LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- GMK Primary Total Knee System 02.07.0310SFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer4 reports
- GMK Primary Total Knee System 02.07.0512SFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer4 reports
- GMK Primary Total Knee System 02.07.2003RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer4 reports
- GMK Primary Total Knee System 02.07.2204LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer4 reports
- GMK Primary Total Knee System 02.07.0210PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Primary Total Knee System 02.07.0210SFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Primary Total Knee System 02.07.0314SFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Primary Total Knee System 02.07.2005LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Primary Total Knee System 02.07.2205LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Primary Total Knee System 02.07.2206LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Primary Total Knee System 02.07.2212LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Primary Total Knee System 02.07.2214RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Primary Total Knee System 02.07.2216LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Primary Total Knee System 02.07.0214PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Primary Total Knee System 02.07.0310APPSProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Primary Total Knee System 02.07.0317FUCProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Primary Total Knee System 02.07.0517PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Primary Total Knee System 02.07.0520FUCProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Primary Total Knee System 02.07.0610SFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Primary Total Knee System 02.07.2002RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Primary Total Knee System 02.07.2006LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Primary Total Knee System 02.07.2006RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Primary Total Knee System 02.07.2013RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Primary Total Knee System 02.07.2204RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Primary Total Knee System 02.07.2206RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Primary Total Knee System 02.07.2213LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Primary Total Knee System 02.07.2213RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Primary Total Knee System 02.07.2214LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Primary Total Knee System 02.07.F11030Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Primary Total Knee System 02.07.0041IPProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0042IPProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0110PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0110SFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0120PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0210FUCProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0214APUCProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0214SFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0217FUCProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0217PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0317PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0317SFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0320PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0410APPSProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0412SFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0417FUCProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0417PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0420FUCProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0420PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0512APPSProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0514PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0612PSFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.0612SFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.2004RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.2014LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.2015RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.2202RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.2203RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.2205RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.2207RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.2215LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Primary Total Knee System 02.07.2216RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
Recent GMK Primary 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 13, 2026Adverse Event Without Identified Device or Use Problem
Revision surgery after 2 years and 8 months from the primary due to pain.The surgeon revised the tibial tray, insert, femoral component, and patella from GMK-Sphere to GMK-Revision. The surgery was completed successfully.
Patient problems: Implant Pain
MAUDE report 50232825 ↗InjuryAug 11, 2026Device Appears to Trigger Rejection
At about 1 year and 9 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 GMK-Sphere cemented S4 tibial tray to a Rev. Tibial Tray Left S4 and revised the Flex 4L - 11mm insert to a Flex 4L - 13mm at his discretion. The surgery was completed successfully.
Patient problems: Medical device site infection
MAUDE report 50209598 ↗InjuryAug 3, 2026Loosening of Implant Not Related to Bone-Ingrowth
At about 3 years and 7 months from the primary, the patient came in reporing paindue to loosening of the tibial trayand the cause is unknown. The surgeon revised all components and the surgery was completed successfully.
Patient problems: Aseptic loosening; Implant Pain
MAUDE report 50114139 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
At about 3 years 10 months after the primary, the patient came in reporting instability and the cause of the instability is unknown. The surgeon revised all components to GMK-hinge components and the surgery was completed successfully.
Patient problems: Joint Laxity
MAUDE report 50114132 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
Revision surgery due to patella maltracking and dislocation after about 1 year and 4 months from primary. All knee implants were revised using competitors implants. The primary was performed using MyKnee patient match cutting block.
Patient problems: Joint Dislocation
MAUDE report 50114124 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
The patient had knee instability and the cause is unknown. At about 14 years and 10 months post primary the surgeon upsized the insert and the surgery was completed successfully.
Patient problems: Joint Laxity
MAUDE report 50114119 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
Revision surgery after 5 months from the primary due to infection. The surgeon revised all the components to match those of the competitor.
Patient problems: Medical device site infection
MAUDE report 50005872 ↗InjuryJul 22, 2026Device Appears to Trigger Rejection
AT ABOUT 7 YEARS AND 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE STD. 10MM S3 INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25904758 ↗InjuryJul 22, 2026Device Appears to Trigger Rejection
AT ABOUT 2 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25904708 ↗InjuryJul 22, 2026Device Appears to Trigger Rejection
REVISION SURGERY WAS PERFORMED 1 MONTH AND HALF AFTER THE PRIMARY DUE TO INFECTION. THE SURGEON REMOVED ALL IMPLANTS AND PLACED ANTIBIOTIC SPACER. DURING THE PRIMARY SURGICAL PROCEDURE THE MEDACTA REPRESENTATIVE EXPERIENCED A MEDICAL EVENT, LOST CONSCIOUSNESS, AND FELL INTO THE OPEN SURGICAL FIELD ON THE SURGICAL DRAPS BEFORE COLLAPSING ONTO THE FLOOR. FOLLOWING THE EVENT, THE SURGEON INITIATED THE DISINFECTION PROTOCOL DUE TO THE POTENTIAL CONTAMINATION RISK OF THE SURGICAL SITE.
Patient problems: Medical device site infection
MAUDE report 25904707 ↗InjuryJul 16, 2026Implant subsidence
REVISION SURGERY DUE TO TIBIAL SUBSIDENCE AFTER ABOUT 5 YEARS AND 4 MONTHS FROM PRIMARY. THE SURGEON REVISED TIBIAL TRAY AND INSERT. THE PATIENT HAD A FIRST REVISION SURGERY ON (B)(6) 2023 WHERE THE SURGEON REVISED THE FEMORAL COMPONENT AND TIBIAL INSERT (MDR 3005180920-2023-00515)-
Patient problems: Implant Pain
MAUDE report 25838727 ↗InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF A FALL OR TRAUMA. AT ABOUT 1 YEAR AND 3 MONTHS POST PRIMARY THE SURGEON REVISED THE PS INSERT FROM A 10MM TO A 12MM TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Laxity
MAUDE report 25813735 ↗InjuryJul 14, 2026Loosening of Implant Not Related to Bone-Ingrowth
AT ABOUT 5 YEARS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING ASEPTIC LOOSENING OF THE TIBIA AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA OR A FALL. THE SURGEON REVISED THE GMK-SPHERE TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT TO GMK-HINGE IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 25813729 ↗InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD PAIN DUE TO THE PATELLA NOT TRACKING PROPERLY AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. AT ABOUT 4 YEARS AND 10 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA PATELLA TO A COMPETITOR PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 25763502 ↗InjuryJul 8, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE PATIENT UNDERWENT PRIMARY SURGERY ON (B)(6) 2025. APPROXIMATELY ONE YEAR AFTER SURGERY, THE PATIENT EXPERIENCED PAIN IN THE JOINT, AND X-RAYS CONFIRMED TIBIAL LOOSENING. A REVISION SURGERY IS SCHEDULED FOR (B)(6), 2026.
Patient problems: Aseptic loosening
MAUDE report 25747736 ↗
Other Medacta International SA products
- GMK Sphere Total Knee System209 models · 2,306 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
- GMK Revision Total Knee System71 models · 304 reports
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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