GMK Sphere Total Knee System 02.12.0312FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07630030826375), received between Feb 2, 2018 and Jan 10, 2025 — classified as 23 injuries.

The most frequently reported specific device problem is “Unstable” (5 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT ABOUT 2 YEARS AND 7 MONTHS POST-PRIMARY THE SURGEON REVISED THE INSERT, IMPLANTING A 8MM THICKER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21122124 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 4 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (FROM 12MM TO 20MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20555205 ↗
• InjuryNov 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 6 YEARS AND 1 MONTH POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18054069 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AND 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE LINER (12 TO 14 MM).

  Patient problems: Joint Laxity

  MAUDE report 17265740 ↗
• InjuryMar 21, 2023Adverse 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. REVISION SURGERY AT ABOUT 3 MONTHS FROM PRIMARY THE SURGEON REVISED THE INSERT, IMPLANTING A 5MM THICKER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16583042 ↗
• InjuryApr 8, 2022Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS ALMOST 1 YEAR AND 7 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 14051922 ↗
• InjuryFeb 17, 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 AND 4 MONTHS 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 13547747 ↗
• InjuryDec 22, 2021Unstable

  AT 3 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (12 MM TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13058615 ↗
• InjuryOct 29, 2021Unstable

  ON (B)(6) 2021, AT 3 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON IMPLANTED THICKED LINER DUE TO THE PATIENT HAD SOME INSTABILITY TOO. SUBSEQUENTLY, ON (B)(6) 2021, THE PATIENT HAD ANOTHER LINER REVISION DUE TO INFECTION AND INSTABILITY. THE LINER WAS UPSIZED SUCCESSFULLY. IN BOTH CASES THE PATHOGEN IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12720053 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem

  1 MONTH AND 15 DAYS 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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12615661 ↗
• InjuryJul 15, 2021Appropriate Device Problem Term/Code Not Available

  4 DAYS AFTER PRIMARY SURGERY THE INLAY WAS REVISED BECAUSE OF A SUPPOSED EARLY LOW GRADE INFECT.

  Patient problems: Unspecified Infection

  MAUDE report 12172070 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN 14 DAYS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10718014 ↗
• InjuryOct 2, 2020Unstable

  INSTABILITY OF A KNEE PROSTHESIS IMPLANTED IN 2015. LIGAMENTOUS CONDITION WAS VERY CRITICAL, LINER 12MM HAS BEEN REVISED WITH A 17MM ONE 4 YEARS AND 11 MONTHS AFTER PRIMARY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10619433 ↗
• InjuryMar 16, 2020Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO LAXITY IN THE KNEE. THE CAUSE OF THE LAXITY IS UNKNOWN. 1 YEAR AND 2 MONTHS AFTER PRIMARY SURGERY THE SURGEON REVISED THE MEDACTA SPHERE INSERT FLEX LEFT 12MM S3 WITH A MEDACTA SPHERE INSERT FLEX LEFT 17MM S3. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9834571 ↗
• InjuryOct 2, 2019Appropriate Device Problem Term/Code Not Available

  ON THE 6 SEPTEMBER 2019 WE WERE INFORMED OF A REVISION SURGERY PERFORMED ON THE 10 SEPTEMBER 2019 ALMOST 2 YEARS AND 8 MONTHS AFTER PRIMARY DUE TO UNSCREWING OF THE INSERT SCREW. NO TORQUE LIMITER USED DURING PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9144398 ↗
• InjuryJul 17, 2019Appropriate Device Problem Term/Code Not Available

  18 DAYS AFTER THE FIRST REVISION SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE POLY AND PERFORMED A WASHOUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8797315 ↗
• InjuryJul 5, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 3 MONTHS AFTER PRIMARY, 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 8764332 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED AFTER 2 WEEKS FROM THE PRIMARY DUE TO SIGNS OF INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8757356 ↗
• InjuryJun 6, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A HIP INFECTION. THE PATHOGEN IS UNKNOWN. ABOUT 2 YEARS AFTER PRIMARY THE SURGEON PERFORMED AN I&D AND INSERT-SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8673854 ↗
• InjuryJul 20, 2018Patient-Device Incompatibility

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 2 MONTHS AFTER PRIMARY. THE WBC COUNT WAS HIGH YET CULTURES CAME BACK NEGATIVE. THE SURGEON PERFORMED AN I&D AND SWAPPED THE POLY FOR PREVENTATIVE PURPOSES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 7706389 ↗
• InjuryJul 11, 2018Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO INSTABILITY AND ANTERIOR KNEE PAIN 2 YEARS AFTER PRIMARY. THE SURGEON UPSIZED THE POLY AND RESURFACED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Arthralgia

  MAUDE report 7677472 ↗
• InjuryJun 13, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 MONTH AFTER THE PRIMARY. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. NOTE: THE PATIENT WAS SEPTIC.

  Patient problems: Unspecified Infection

  MAUDE report 7596022 ↗
• InjuryFeb 2, 2018Unstable

  REVISION SURGERY PERFORMED DUE TO KNEE INSTABILITY AFTER ABOUT 1 YEAR FROM PRIMARY. THE SURGEON REVISED THE 12MM LINER TO A 14MM LINER.

  Patient problems: Joint Disorder

  MAUDE report 7237455 ↗