GMK Sphere Total Knee System 02.12.0514FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07630030826818), received between Dec 7, 2017 and Jul 10, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (2 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THERE ARE NO INDICATIONS OF TRAUMA OR A FALL. AT ABOUT 7 YEARS AND 10 MONTHS POST PRIMARY THE SURGEON REVISED THE FLEX S5L - 14MM INSERT TO A FLEX 5L - 17MM TO INCREASE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 25778123 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AT ABOUT 7 YEARS AND 9 MONTHS DUE TO INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-SPHERE 14MM INSERT TO A GMK-SPHERE 17MM INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24454892 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO KNEE PAIN. THE SURGEON OBSERVED PATELLA MALTRACKING ISSUES AND LAXITY. ABOUT 2 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON UPSIZED THE INSERT (FROM 14MM TO 17MM) AND RESURFACED THE PATIENT & SIZE 39S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23615705 ↗
• MalfunctionNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT REPORTS KNEE PAIN DUE TO SWELLING AND LAXITY, PROBABLY RELATED TO STRENUOUS EXERCISE ACTIVITY. IT WAS A BILATERAL INSTABILITY, SO THE SURGEON REVISED THE INSERTS IN BOTH KNEES (LEFT KNEE FROM 14 MM TO 16 MM; RIGHT KNEE FROM 10 MM TO 11 MM AND SCAR TISSUE REMOVAL). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23615334 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 4 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON UPSIZED THE POLY (FROM 14 TO 17MM)AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22411000 ↗
• InjuryDec 22, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO PAIN AT 1 YEAR AND 3 MONTHS FROM THE PRIMARY. THE REASON OF THE PAIN IS UNKNOWN. GMK-SPHERE WITH EXTENSION STEM IMPLANTED.

  Patient problems: Implant Pain

  MAUDE report 18382650 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (FROM 14MM TO 17MM) AND RESURFACED THE PATIENT'S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17912052 ↗
• InjuryApr 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO LEFT KNEE INSTABILITY. NO INFECTION AND NO LOOSENING OF THE IMPLANTS WERE FOUND. THE SURGEON REVISED SUCCESSFULLY THE TIBIAL TRAY (SIZE 5), WITH A TRAY OF THE SAME SIZE, AND THE INSERT (FROM 14MM TO 12MM) AND IMPLANTED TWO TIBIAL WEDGES CEMENTED (10MM) AND AN EXTENSION STEM (11MM/65MM).

  Patient problems: Joint Laxity

  MAUDE report 16807150 ↗
• InjuryJun 3, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 MONTH AFTER THE PRIMARY SURGERY, 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 11931389 ↗
• InjuryJun 1, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A TIBIAL SUBSIDENCE. THE CAUSE OF THE TIBIAL SUBSIDENCE IS UNKNOWN. 1 YEAR AND 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE TIBIAL TRAY, INSERT, AND IMPLANTED TIBIAL AUGMENTS, AN OFFSET CONNECTOR, AND A FLUTED EXTENSION STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11911480 ↗
• InjuryApr 7, 2021Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE SPHERE INSERT FLEX LEFT 14MM S5 WITH A GMK-SPHERE TIBIAL INSERT - FLEX S5L - 17 MM TO GIVE THE PATIENT MORE STABILITY 5 YEARS AND 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11626624 ↗
• InjuryFeb 12, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO ANTERIOR KNEE PAIN 1 YEAR AND 4 MONTHS AFTER THE PRIMARY. THE SURGEON RESURFACED THE PATELLA. THE PATIENT ALREADY UNDERWENT REVISION SURGERY DUE TO SUPERFICIAL INFECTION WHERE THE INLAY WAS REVISED IN (B)(6) 2019.

  Patient problems: Unspecified Infection

  MAUDE report 11320736 ↗
• InjuryJan 22, 2021Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO INSTABILITY, 2 YEARS AFTER THE PRIMARY. THE CAUSE OF INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE 14 MM INSERT WITH 17 MM INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 11214861 ↗
• InjuryOct 28, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 2 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN DUE TO HAVING FLUID BUILDUP. THE SURGEON DRAINED THE PATIENT'S KNEE AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inflammation

  MAUDE report 10747791 ↗
• InjuryDec 3, 2019Appropriate Device Problem Term/Code Not Available

  SECOND REVISION SURGERY 14 DAYS AFTER THE FIRST REVISION DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE FIRST REVISION SURGERY WAS PERFORMED ONE DAY BEFORE THE SECOND REVISION DUE TO THE PATIENT FELL AND HIS KNEE SPLIT OPEN (WASHOUT AND INSERT SWAP).

  Patient problems: Unspecified Infection

  MAUDE report 9401246 ↗
• InjuryApr 25, 2018Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE CAUSE OF INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE 14MM LINER FOR A 17MM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7458219 ↗
• InjuryDec 7, 2017Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED DUE TO SIGNS OF INFECTION ABOUT 1 YEAR AFTER PRIMARY. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE LINER.

  Patient problems: Unspecified Infection

  MAUDE report 7095273 ↗