GMK Sphere Total Knee System 02.12.0006RRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030825880), received between Oct 24, 2018 and Jun 9, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Device Appears to Trigger Rejection

  AT ABOUT 5 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA IMPLANTS AND IMPLANTED ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25442545 ↗
• InjuryMar 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 YEAR AND 3 MONTHS FROM MEDACTA PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21503937 ↗
• InjuryOct 15, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  FIRST STAGE KNEE REVISION FOR INFECTION AT ABOUT 10 YEARS AND 3 MONTHS POST PRIMARY. ALL IMPLANTS WERE REMOVED AND WASHOUT WAS PERFORMED. A COMPETITOR SPACER WAS IMPLANTED AS THE JOINT WAS INFECTED. AFTER A CHECK OF THE AGENT WITH THE HOSPITAL, NO FURTHER INFORMATION WILL BE AVAILABLE REGARDING THE 2ND STAGE REVISION OR THE PATIENT.

  Patient problems: Medical device site infection

  MAUDE report 20448872 ↗
• InjurySep 23, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY AT ABOUT 2 YEARS AND 5 MONTHS POST PRIMARY FOR FEMUR AND TIBIA LOOSENING. ALL THE DEVICES HAVE BEEN REVISED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15473602 ↗
• InjuryJun 18, 2021Unstable

  THE PATIENT CAME IN REPORTING MID-FLEXION INSTABILITY 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED ALL IMPLANTS AND CONVERTED THE PATIENT FROM A SPHERE KNEE TO A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12024588 ↗
• InjuryAug 26, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE TIBIA AND FEMUR. THE SURGEON OBSERVED THAT THERE WAS NO CEMENT PRESENT ON THE IMPLANTS. THE SURGEON REVISED THE FEMUR, TIBIA, AND INSERT 7 YEARS AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10453190 ↗
• InjuryJun 24, 2020Loose or Intermittent Connection; Unstable; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE FEMORAL COMPONENT. THE SURGEON REVISED ALL IMPLANTS AND CONVERTED THE GMK SPHERE KNEE TO A GMK HINGE KNEE 1 YEAR AND 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10188722 ↗
• InjuryOct 24, 2018Unstable

  CEMENT DIDN'T ADHERE TO IMPLANTS. THE TYPE OF CEMENT USED IS PALACOS R. ADDITIONAL COMMENT PERFORMED BY SURGEON: APPARENTLY A SURGEON HAS REVISED TWO OTHER PATIENTS OF MINE OVER THE LAST YEAR OR SO THAT WERE BOTH MEDACTA KNEES. IN BOTH OF THOSE CASES THERE WAS NO ADHERENCE OF CEMENT TO THE METAL COMPONENTS. FROM WHAT I UNDERSTAND, ONE OF THE KNEES WAS REVISED BECAUSE OF MID FLEXION INSTABILITY AND THE OTHER ONE HAD INCOMPETENCE OF THE MEDIAL COLLATERAL LIGAMENT.

  Patient problems: No Code Available

  MAUDE report 7999378 ↗