GMK Sphere Total Knee System 02.12.0413FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07630030862618), received between Aug 30, 2017 and Dec 6, 2023 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2023Migration; Migration

  AT ABOUT 5 YEARS FROM THE PRIMARY, DURING A FOLLOW-UP VISIT, IT WAS NOTED FROM THE X-RAYS THAT THE INLAY LOCKING SCREW WAS LOOSE IN THE POSTEROLATERAL ASPECT OF THE KNEE. ABOUT 7 YEARS AFTER THE PRIMARY SURGERY, A SECOND FOLLOW-UP SHOWED THAT THE SCREW HAS NOT MOVED. AT THIS TIME, AN ADDITIONAL/REVISION SURGERY IS NOT PLANNED, THE PATIENT DOES NOT FEEL ANY PAIN AND HAS A FULL RANGE OF MOVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18274789 ↗
• InjuryAug 9, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 8 MONTHS 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 SUCCESSFULLY THE LINER.

  Patient problems: Unspecified Infection

  MAUDE report 17486502 ↗
• InjuryApr 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. ON (B)(6) 2022, 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. ON (B)(6) 2023, 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. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16732183 ↗
• InjuryMar 8, 2022Unstable

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY WAS UNKNOWN. THE SURGEON REVISED THE INSERT AND PATELLA AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, ONE MONTH AFTER THE PRECEDENT SURGERY, 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 13693413 ↗
• InjuryJan 27, 2022Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE 13MM POLY WITH A 17MM POLY 3 YEARS AND 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 13365850 ↗
• InjuryNov 3, 2021Appropriate Device Problem Term/Code Not Available

  AT 17 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12743396 ↗
• InjuryJul 15, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. 5 YEARS AFTER PRIMARY THE SURGEON REVISED THE SPHERE INSERT FLEX LEFT 13MM S4 WITH A GMK-SPHERE TIBIAL INSERT - FLEX S4L - 20 MM TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12171586 ↗
• InjuryJul 9, 2021Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. 3 YEARS AND 9 MONTHS AFTER PRIMARY THE SURGEON REVISED THE SPHERE INSERT FLEX LEFT 13MM S4 WITH A GMK-SPHERE TIBIAL INSERT - FLEX S4L - 20 MM TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12142431 ↗
• InjuryJul 7, 2021Appropriate Device Problem Term/Code Not Available

  6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON REVISED THE TIBIAL COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 12126587 ↗
• InjuryJan 27, 2021Unstable

  AFTER 1 YEAR AND 9 MONTHS AFTER THE PREVIOUS REVISION SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE SPHERE INSERT FLEX LEFT 13MM S4 WITH A GMK-SPHERE TIBIAL INSERT - FLEX S4L - 17MM TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE FIRST REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY( LINER REVISION 11 MM TO 13MM).

  Patient problems: Joint Laxity

  MAUDE report 11235032 ↗
• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT 15 DAYS AFTER THE PRIMARY SURGERY AND IT WAS OBSERVED THAT A HEMATOMA HAD DEVELOPED. THE CAUSE OF THE HEMATOMA IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hematoma

  MAUDE report 10572758 ↗
• InjuryApr 3, 2020Loose or Intermittent Connection

  AFTER 1 YEAR AND 3 MONTHS FROM THE PREVIOUS REVISION, THE PATIENT CAME IN REPORTING PAIN DUE TO LAXITY IN BOTH KNEES. THE SURGEON REVISED THE LEFT KNEE FROM A MEDACTA SPHERE INSERT FLEX LEFT 13MM S4 TO A MEDACTA SPHERE INSERT FLEX LEFT 17MM S4 AND REVISED THE RIGHT KNEE FROM A MEDACTA SPHERE INSERT FLEX RIGHT 10MM S4 TO A MEDACTA SPHERE INSERT FLEX RIGHT 12MM S4. THE SURGEON ALSO RESURFACED BOTH PATELLA'S. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS THE SECOND REVISION SURGERY FOR THIS PATIENT (DURING THE PREVIOUS REVISION SURGERY DUE TO LAXITY IN THE LEFT KNEE, THE EXTENSION STEM, INSERT AND TIBIAL TRAY WERE REVISED).

  Patient problems: Joint Disorder

  MAUDE report 9920579 ↗
• InjuryNov 15, 2018Adverse Event Without Identified Device or Use Problem

  INFECTION FOLLOWED BY A LINER EXCHANGE OF A GMK-SPHERE KNEE 1 MONTH AFTER PRIMARY SURGERY. THE LINER WAS CHANGED WITH A NEW ONE OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 8073330 ↗
• InjuryMay 16, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE INFECTION WAS POSSIBLY CAUSED BY A TOOTH ABSCESS. THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7518548 ↗
• InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem

  ABOUT 3 YEARS AFTER PRIMARY THE TIBIAL INLAY SCREW COME OUT. THE SURGEON REMOVED IT ARTHROSCOPICALLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 7486985 ↗
• InjuryAug 30, 2017Insufficient Device Problem Information

  THE PATIENT HAD MODERATE PAIN, POSITIVE LOCAL THERMOTACTIC PARAMETERS, AND IRREGULAR FLOGIC INDEXES. EXAMINATIONS REVEALED THE PRESENCE OF STAPHYLOCOCCUS WARNERI. REVISION SURGERY PERFORMED APPROXIMATELY TWO MONTHS AFTER PRIMARY DUE TO INFECTION. THE SURGEON PERFORMED A SURGICAL WASH-OUT AND REPLACED THE INSERT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 6829706 ↗