GMK Revision Total Knee SystemRecalls & reported problems across all models
Medacta International SA · 71 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 304
- Deaths reported
- 0
- Injuries reported
- 294
- Recalls
- 0
We found 71 models of GMK Revision Total Knee System by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 304 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2017 and Aug 3, 2026 — classified as 294 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (81 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 Revision Total Knee System problems
Device problems
- Device Appears to Trigger Rejection81
- Adverse Event Without Identified Device or Use Problem76
- Appropriate Device Problem Term/Code Not Available66
- Loosening of Implant Not Related to Bone-Ingrowth14
- Unstable14
- Loose or Intermittent Connection11
- Device Dislodged or Dislocated7
- Fracture6
Patient problems
- Unspecified Infection119
- Medical device site infection51
- Joint Laxity31
- Pain19
- Joint Disorder18
- Loss of Range of Motion15
- No Known Impact Or Consequence To Patient12
- Implant Pain10
GMK Revision Total Knee System models
71 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GMK Revision Total Knee System 02.07.0414SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer18 reports
- GMK Revision Total Knee System 02.07.0314SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer14 reports
- GMK Revision Total Knee System 02.07.0410SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer14 reports
- GMK Revision Total Knee System 02.07.0417SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer14 reports
- GMK Revision Total Knee System 02.07.0214SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer13 reports
- GMK Revision Total Knee System 02.07.0310SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer13 reports
- GMK Revision Total Knee System 02.07.0514SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer13 reports
- GMK Revision Total Knee System 02.07.0217SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer12 reports
- GMK Revision Total Knee System 02.07.0312SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer12 reports
- GMK Revision Total Knee System 02.07.0510SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer10 reports
- GMK Revision Total Knee System 02.07.0317SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer9 reports
- GMK Revision Total Knee System 02.07.0412SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer9 reports
- GMK Revision Total Knee System 02.07.0517SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer8 reports
- GMK Revision Total Knee System 02.07.0220SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer7 reports
- GMK Revision Total Knee System 02.07.0512SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer7 reports
- GMK Revision Total Knee System 02.07.0210SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Revision Total Knee System 02.07.0212SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6 reports
- GMK Revision Total Knee System 02.07.0320SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- GMK Revision Total Knee System 02.07.0326SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- GMK Revision Total Knee System 02.07.0682LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- GMK Revision Total Knee System 02.07.2403LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- GMK Revision Total Knee System 02.07.2404LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- GMK Revision Total Knee System 02.07.2404RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- GMK Revision Total Knee System 02.07.0617SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer4 reports
- GMK Revision Total Knee System 02.07.0682RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer4 reports
- GMK Revision Total Knee System 02.07.0005Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Revision Total Knee System 02.07.0420SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Revision Total Knee System 02.07.0423SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Revision Total Knee System 02.07.0520SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Revision Total Knee System 02.07.0683LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Revision Total Knee System 02.07.0684LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Revision Total Knee System 02.07.0684RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Revision Total Knee System 02.07.2402LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Revision Total Knee System 02.07.2402RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Revision Total Knee System 02.07.FCL18105Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- GMK Revision Total Knee System 02.07.0110SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Revision Total Knee System 02.07.0112SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Revision Total Knee System 02.07.0223SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Revision Total Knee System 02.07.0226SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Revision Total Knee System 02.07.0620SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Revision Total Knee System 02.07.0683RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Revision Total Knee System 02.07.0685LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Revision Total Knee System 02.07.2401RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Revision Total Knee System 02.07.2403RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Revision Total Knee System 02.07.2405LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Revision Total Knee System 02.07.2405RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Revision Total Knee System 02.07.2406LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Revision Total Knee System 02.07.2406RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Revision Total Knee System 02.07.FCL11065Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Revision Total Knee System 02.07.FCL16065Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- GMK Revision Total Knee System 02.07.0003Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.0114SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.0323SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.0426SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.0523SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.0610SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.0612SCFProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.0681LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.2401LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.2503LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.310FPWProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.404FDWProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.FCL12065Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.FCL13105Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.FCL13150Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.FCL14065Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.FCL15065Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.FCL15105Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.FCL18065Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.FCL22065Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- GMK Revision Total Knee System 02.07.FSC13105Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
Recent GMK Revision 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 3, 2026Device Appears to Trigger Rejection
The patient had primary surgery using competitor products. On (b)(6) 2025, the patient was revised to Medacta GMK-Revision implants. On (b)(6) 2025, the patient came in with inflammation/infection over incision site with unknown cause. The surgeon performed washout and revised the knee implant. The surgery was completed successfully "[MDR 2025-00787]". 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 17mm S4 semiconstrained insert to a same size insert. The surgery was completed successfully.
Patient problems: Medical device site infection
MAUDE report 50114128 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
Revision surgery due to knee instability after about 3 years and 7 months from primary. The surgeon revised the femur with a femur of the same size with distal and posterior augments and upsized the poly for more stability.
Patient problems: Joint Laxity
MAUDE report 50114122 ↗InjuryJul 9, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION AFTER ABOUT 3 YEARS AND 7 MONTHS FROM FIRST REVISION SURGERY. THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY USING COMPETITOR PRODUCTS. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT AND THE TINBN COATED SC.
Patient problems: Medical device site infection
MAUDE report 25763499 ↗InjuryJul 9, 2026Device Appears to Trigger Rejection
REVISION SURGERY AFTER3 YEARS FROM THE PRIMARY DUE TO INFECTION. THE SURGERY WAS COMPLETED.
Patient problems: Medical device site infection
MAUDE report 25763462 ↗InjuryJul 8, 2026Device Appears to Trigger Rejection
THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2025, THE PATIENT WAS REVISED TO MEDACTA GMK-REVISION IMPLANTS. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVE ALL REVISION IMPLANTS FROM THE (B)(6) 2025 SURGERY. THE SURGEON PLACE ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25747729 ↗InjuryMay 27, 2026Device Appears to Trigger Rejection
AT ABOUT 2 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT AND THE PEG. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25297698 ↗InjuryMay 27, 2026Device Appears to Trigger Rejection
THE PATIENT HAD PRIMARY LEFT KNEE SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2025, THE PATIENT WAS REVISED TO MEDACTA SPACERS FOR INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2026, THE PATIENT HAD PERMANENT MEDACTA GMK-REVISION HARDWARE IMPLANTED (FEMORAL COMPONENT, INSERT, TIBIAL TRAY). 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 SEMICONSTRAINED 10MM S4 INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25297686 ↗InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2025, THE SURGEON REVISED THE PATIENT TO MEDACTA GMK-REVISION IMPLANTS. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING ANTERIOR PAIN AND INSTABILITY. THE SURGEON REVISED THE SEMICONSTRAINED 14MM S5 INSERT TO A SEMICONSTRAINED S5 17MM INSERT AND REVISED THE PATIENT`S NATURAL PATELLA USING COMPETITOR PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 25253492 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY AFTER 1 MONTH DUE TO INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE SEMICONSTRAINED 14MM S4 INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25230411 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
AT 10 MONTHS FROM MEDACTA PRIMARY SURGERY, THE PATIENT CAME IN PRESENTING PAIN AND SEVERE FLEXION CONTRACTURE AND THE CAUSE IS UNKNOWN. THERE WERE NO REPORTS OF TRAUMA. THE SURGEON REVISED THE SEMICONSTRAINED 12MM S5 INSERT TO A SEMICONSTRAINED 10MM S5 INSERT, PERFORMEDADDITIONAL DISTAL RESECTION TO GAIN FULL EXTENSIONAND REVISED THE PS SIZE 5 R FEMUR WITH THE SAME SIZE FEMUR ALONG WITH AUGMENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Loss of Range of Motion
MAUDE report 25185346 ↗InjuryMay 8, 2026Device Appears to Trigger Rejection
THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY USING COMPETITOR IMPLANTS AND ON (B)(6) 2024, WAS REVISED TO MEDACTA GMK-REVISION IMPLANTS. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATIENT WAS DIAGNOSED WITH A PERFORATED DIVERTICULITIS WHICH THEN LED TO EFFUSION AND REDNESS IN THEIR RIGHT KNEE. THE SURGEON PERFORMED A WASHOUT, SOFT TISSUE RELEASE AND REVISED THE SEMICONSTRAINED 17MM S4 INSERT TO A SEMICONSTRAINED 20MM S4 INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25123200 ↗InjuryApr 20, 2026Migration
X-RAYS TAKEN 8 YEARS 7 MONTHS AFTER THE PRIMARY REVEALED THAT THE EXTENSION STEM SCREW CONNECTING THE FEMUR AND THE OFFSET WAS UNSCREWED AND HAD MIGRATED.THE SCREW WAS REMOVED THROUGH A SMALL INCISION.THE TORQUE LIMITER WAS USED DURING PRIMARY SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24924648 ↗InjuryApr 9, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION 5 YEARS AND 2 MONTHS AFTER FIRST REVISION SURGERY. THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY USING COMPETITOR PRODUCTS. THE SURGEON PERFORMED A WASHOUT AND UPSIZED THE SEMICONSTRAINED 17MM S4 LINER TO A SEMICONSTRANED 23MM S4 LINER AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24826100 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
AT 4 YEARS 4 MONTHS FROM MEDACTA PRIMARY SURGERY, THE PATIENT CAME IN DUE TO INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON OBSERVED THAT THE BONE/TISSUE QUALITY WAS POOR. THE SURGEON REVISED THE SEMICONSTRAINED 20MM S5 INSERT TO A SEMICONSTRAINED 23MM S5 INSERT AND REVISED THE TINBN COATED 20MM PEG TO A TINBN COATED 23MM PEG. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 24826095 ↗InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY WITH GMK-SPHERE COMPONENTS. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING ANTERIOR PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS WITH REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY MDR 2024-00690. ON (B)(6) 2026, THE PATIENT CAME IN REPORTING STIFFNESS AND LACK OF RANGE OF MOTION AND THE CAUSE IS UNKNOWN. THE SURGEON DOWNSIZED THE POLY TO GIVE THE PATIENT MORE RANGE OF MOTION. THE SURGERY WAS COMPLETED SUCCESSFULLY MDR2025-00810. ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING LIMITED RANGE OF MOTION WITH A STIFF KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE 11MM INSERT TO A 10MM INSERT AND REVISED THE 14MM PEG TO A 10MM PEG. THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANTED - 02.07.0310SCF INSERT SEMICONSTRAINED 10MM S3 2523107 02.07. SCP10 TINBN COATED SC PEG - 10MM 2112334.
Patient problems: Loss of Range of Motion
MAUDE report 24738826 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page