GMK Sphere Total Knee System 02.12.0007RRecalls & reported problems
Medacta International SA · Femur Sphere cemented Right, size 7 · Class 2 · Implant
All models of GMK Sphere Total Knee System (209)
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 07630030825903), received between Jan 21, 2020 and Oct 28, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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
- Device Appears to Trigger Rejection1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Unstable1
Patient problems
- Implant Pain1
- Joint Disorder1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 28, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 5 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 FEMORAL COMPONENT AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 20545290 ↗InjuryFeb 8, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY FOR FEMORAL LOOSENING AT ABOUT 3 YEARS AND 8 MONTHS POST PRIMARY. LINER AND FEMUR REVISED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 16329560 ↗InjuryJan 21, 2020Unstable
THE PATIENT CAME IN COMPLAINING OF INSTABILITY 3 MONTHS AFTER PRIMARY SURGERY. THE SURGEON FIRST TRIALED THE 17MM SPHERE POLY WHICH IMPROVED STABILITY IN FLEXION AND EXTENSION HOWEVER, SOFT TISSUE INSTABILITY IN MID FLEXION RANGE REMAINED A MAJOR ISSUE. THE SURGEON DECIDED TO CONVERT ALL THE SPHERE COMPONENTS (THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT) TO A HINGE KNEE IN ORDER TO USE AUGMENTS AND PROVIDE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Disorder
MAUDE report 9610263 ↗
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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