GMK Sphere Total Knee System 02.12.0510FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 07630030826740), received between Aug 16, 2017 and Mar 3, 2026 — classified as 99 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (21 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, 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Device Appears to Trigger Rejection

  KNEE REVISION SURGERY ON THE RIGHT SIDE FOR INFECTION (STAPHYLOCOCCUS AUREUS). AT ABOUT 20 DAYS FROM PRIMARY SURGERY LINER SWAPPED SUCCESSFULLY DURING REVISION SURGERY.

  Patient problems: Medical device site infection

  MAUDE report 24494917 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 YEARS 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON RESURFACED THE PATIENT&RSQUOS NATIVE PATELLA AND SWAPPED THE 10MM POLY WITH A 12MM POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 23850110 ↗
• InjuryDec 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN REPORTING KNEE INFECTION. AT 7 YEARS AND 2 MONTHS POST PRIMARY THE SURGEON REVISED THE INSERT AND REMOVED THE PATIENT`S PATELLA IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23837359 ↗
• InjuryNov 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 3 YEARS AND 6-MONTHS, THE PATIENT CAME IN DUE TO AN INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23579771 ↗
• InjuryNov 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER7 MONTHS FROM THE PRIMARY THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23477196 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY (10 TO 12 MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22573681 ↗
• InjuryJul 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 YEARS AND 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 AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22507652 ↗
• InjuryApr 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 9 MONTHS FROM THE 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21751454 ↗
• InjuryMar 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ABOUT 9 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT REPORTED ANTERIOR KNEE PAIN AND THE SURGEON PERFORMED AN ADDITIONAL SURGERY AND RESURFACED PATIENT NATURAL PATELLA. INLAY LOCKING SCREW UNSCREWING (NOT FREE IN THE JOINT) WAS DETECTED DURING THIS SURGERY. THE INLAY LOCKING SCREW HAS BEEN SCREWED BACK ON. TORQUE LIMITER WAS NOT AVAILABLE DURING THE PRIMARY SURGERY.

  Patient problems: Pain

  MAUDE report 21717303 ↗
• InjuryMay 28, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 4 YEARS AND 4 MONTHS POST-PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19403566 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (FROM 10 MM TO 12 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19310773 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD ANTERIOR KNEE PAIN AND INSTABILITY AND THE CAUSE WAS UNKNOWN. AT ABOUT 2 YEARS AND 7 MONTHS POST-PRIMARY THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE POLY, IMPLANTING A THICKER ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19229030 ↗
• InjuryApr 19, 2024Use of Device Problem; Use of Device Problem

  THE PATIENT CAME IN REPORTING PAIN. ABOUT 8 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE POLY (FROM 10 TO 13 MM) AND RESURFACED THE NATURAL PATELLA. DURING THE REVISION, IT WAS NOTED THAT A RIGHT INSERT WAS IMPLANTED IN THE LEFT KNEE DURING THE PRIMARY SURGERY. IT IS UNKNOWN HOW THIS OCCURRED AND THE ISSUE WAS ONLY NOTED DURING THE EXPLANTATION OF THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL NOTE: FEMORAL COMPONENT AND TIBIAL TRAY ARE LEFT.

  Patient problems: Joint Laxity

  MAUDE report 19141714 ↗
• InjuryApr 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 YEAR AND 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING DISCOMFORT DUE TO THE INABILITY TO REACH FULL FLEXION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT AND TIBIA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 19077268 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 1 YEAR AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON UPSIZED THE INSERT (FROM 10 TO 14 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18854022 ↗
• InjuryNov 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS FROM THE 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18190073 ↗
• InjuryOct 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 YEARS 8 MONTHS AFTER THE 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17868928 ↗
• InjurySep 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17682000 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING STIFFNESS AND TIGHTNESS. THE SURGEON REVISED THE TIBIAL INSERT (10MM) WITH AN INSERT OF THE SAME THICKNESS (10MM) AND PERFORMED A SYNOVECTOMY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 17640274 ↗
• InjuryJul 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED ABOUT 1 MONTH AND A HALF AFTER THE PRIMARY SURGERY, DUE TO INTRA-PROSTHETIC DISLOCATION OF THE LINER FROM THE TIBIAL TRAY. THE LINER WAS NOT PROPERLY ENGAGED DURING THE PRIMARY SURGERY, AS SHOWN IN THE XRAYS PERFORMED 1 DAY POST-OP. LINER REVISED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17360882 ↗
• InjuryJul 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER (WITH A POLY OF THE SAME THICKNESS). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17350423 ↗
• InjuryJul 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 MONTHS AFTER THE PRIMARY, REVISION SURGERY PERFORMED DUE TO INFECTION. THE SURGEON COMPLETED DARE PROCEDURE (DEBRIDEMENT & WASHOUT) WITH MULTIPLE SAMPLE TAKEN AND REVISED SUCCESSFULLY THE LINER (SAME SIZE).

  Patient problems: Unspecified Infection

  MAUDE report 17296860 ↗
• InjuryJun 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 4 YEARS AND 5 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17036590 ↗
• InjuryApr 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 MONTHS POST PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16681950 ↗
• InjuryApr 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN, LAXITY AND INSTABILITY IN FLEXION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16679993 ↗