GMK Sphere Total Knee System 02.12.0024RRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07630030862403), received between Aug 30, 2018 and Aug 29, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2025Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  ALMOST SEVEN MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH PAIN RELATED TO VALGUS KNEE INSTABILITY, ATTRIBUTED BY THE SURGEON TO MALPOSITIONING DURING THE PRIMARY SURGERY. THE SURGEON REVISED THE FEMORAL COMPONENT, INSERT, TIBIAL TRAY, AND TIBIAL CONE. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22920623 ↗
• InjuryAug 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT CALLED MEDACTA REPORTING PAIN AT ABOUT 3 MONTHS AFTER A PRIMARY TOTAL KNEE REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME AND THE SURGEON DOES NOT HAVE ANY PLANS TO REVISE THE PATIENT.

  Patient problems: Implant Pain

  MAUDE report 22792531 ↗
• InjuryMar 20, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO FEMORAL LOOSENING. THE SURGEON REVISED THE FEMORAL AND TIBIAL INSERTS. SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651032 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING KNEE INSTABILITY AND THE CAUSE OF THE KNEE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT AND FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18959347 ↗
• InjuryMar 15, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, THE PATIENT CAME IN AND HAD THE SPACER REMOVED AND PERMANENT HARDWARE IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13770435 ↗
• InjuryFeb 7, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13468874 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem

  10 MONTHS AFTER THE PRIMARY SURGERY THE SURGEON REVISED ALL IMPLANTS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11830914 ↗
• InjuryOct 16, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  TIBIAL AND FEMORAL LOOSENING. THE REASON IS UNKNOWN. REVISION SURGERY SUCCESSFULLY PERFORMED 3 YEARS AND 6 MONTHS AFTER PRIMARY SURGERY REMOVING FEMORAL AND INSERT COMPONENTS.

  Patient problems: Failure of Implant

  MAUDE report 10689620 ↗
• InjuryJul 17, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  1 YEAR AND 5 MONTHS AFTER PRIMARY SURGERY THE PATIENT HAD KNEE PAIN AND THE SURGEON SUSPECTED OF TIBIAL TRAY LOOSENING. THE SURGEON REVISED THE JOINT FINDING NO TIBIAL TRAY LOOSENING, BUT THE FEMUR WAS LOOSE. THE SURGEON REVISED ALL IMPLANTS SUCCESSFULLY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 10288433 ↗
• InjuryJul 16, 2020Structural Problem

  THE PATIENT CAME IN REPORTING AN INABILITY TO ACHIEVE FULL FLEXION DUE TO NEGATIVE SLOPE IN THE TIBIA. THE REASON OF SLOPE UNKNOWN. 1 YEAR AND 7 MONTHS AFTER PRIMARY THE SURGEON REVISED ALL MEDACTA IMPLANTS AND REPLACED THEM WITH ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10282359 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO A SEPSIS 2 YEARS AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9792949 ↗
• InjuryFeb 12, 2020Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN, 1 YEAR AND 10 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE FEMORAL COMPONENT, INLAY AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE INLAY HAS BEEN REPLACED WITH A 12 MM IMPLANT.

  Patient problems: Joint Disorder

  MAUDE report 9698647 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN AND GRINDING IN THE KNEE JOINT, AFTER 8 MONTHS FORM THE PRIMARY. THE CAUSE OF THE PAIN AND GRINDING IS UNKNOWN. NO REVISION SURGERY HAS BEEN SCHEDULED AT THIS TIME.

  Patient problems: Pain

  MAUDE report 8619674 ↗
• InjuryMay 8, 2019Unstable

  THE PATIENT CAME IN, 6 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN AND INSTABILITY CAUSED BY A CONNECTIVE TISSUE DISORDER. THE SURGEON REVISED THE GMK SPHERE FEMORAL COMPONENT, LINER AND TIBIAL TRAY WITH A GMK HINGE FEMORAL COMPONENT, LINER AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8591157 ↗
• InjuryAug 30, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. [PATHOGEN: STAPH. COAGULASE-NEGATIVE]. THE SURGEON REVISED ALL HARDWARE AND IMPLANTED A SPACER, ON AN UNKNOWN DATE. THE SURGEON IMPLANTED PERMANENT HARDWARE ON (B)(6) 2018. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7832921 ↗