GMK Sphere Total Knee System 02.12.0007LRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030825897), received between Dec 22, 2017 and Feb 6, 2025 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO FEMORAL COMPONENT OVERHANG FEW MONTHS AFTER THE PRIMARY. FEMORAL DOWNSIZING AND INSERT REVISED.

  Patient problems: Insufficient Information

  MAUDE report 21320169 ↗
• InjuryJun 28, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 6 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14839824 ↗
• InjuryMar 19, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD THE PRIMARY SURGERY ON (B)(6) 2020, THE FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO INFECTION, THE TIBIAL INSERT WAS REPLACED. ON (B)(6) 2022 THE INSERT, FEMUR, AND TIBIA WERE REPLACED DUE TO INFECTION AGAIN.

  Patient problems: Unspecified Infection

  MAUDE report 13826326 ↗
• InjuryApr 7, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN AFTER 6 MONTH FROM THE PRIMARY SURGERY REPORTING PAIN DUE TO A RUPTURED PATELLA TENDON. THE CAUSE OF THE RUPTURED PATELLA TENDON IS UNKNOWN. THE SURGEON REVISED THE MEDACTA SPHERE INSERT FLEX LEFT 17MM S1 WITH A MEDACTA SPHERE INSERT FLEX LEFT 20MM S1. THE SURGERY WAS COMPLETED SUCCESSFULLY..

  Patient problems: No Code Available; Pain; Rupture

  MAUDE report 9932763 ↗
• InjuryApr 7, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION 1 YEAR AND 3 MONTHS AFTER PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PLANS TO REMOVE ALL IMPLANTS AND IMPLANT AN ANTIBIOTIC SPACER. MORE DETAILS WILL BE PROVIDED ONCE THE SURGERY IS COMPLETE.

  Patient problems: Unspecified Infection

  MAUDE report 9932761 ↗
• InjuryDec 22, 2017Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE INSERT, TIBIA AND FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 7142965 ↗
• InjuryDec 22, 2017Adverse Event Without Identified Device or Use Problem

  PATIENT HAS REPORTED PAIN AND DISCOMFORT. REVISION WILL OCCUR ON THE (B)(6) 2017. MORE DETAILS TO FOLLOW.

  Patient problems: Pain

  MAUDE report 7142937 ↗