GMK Sphere Total Knee System 02.12.0412FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07630030826580), received between Jul 7, 2017 and May 15, 2026 — classified as 28 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AND 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING ANTERIOR KNEE PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE PATIENT`S NATURAL PATELLA AND THE INSERTFOR STABILITY(FROM 12 TO 17 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25185356 ↗
• InjuryJul 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 3 YEARS AFTHER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22369025 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 YEARS 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE POLY (12 TO 17 MM) AND RESURFACED THE PATIENT'S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21322605 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS AND 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PATELLA PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATELLA IMPLANT AND REVISED THE INSERT (12MM) WITH A THICKER ONE (14MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 20681572 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY 7 DAYS AFTER SURGERY. THE PATIENT HAD THE WOUND OPEN, BUT THE REASON OF IT IS UNKNOWN. DURING REVISION THE SURGEON WASHED OUT THE WOUND AND NOTICED THAT THE KNEE WAS UNSTABLE, SO HE DECIDED TO SWAP THE LINER INSERTING A 2MM THICKER ONE.

  Patient problems: Joint Laxity

  MAUDE report 19633343 ↗
• InjuryDec 5, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  AT ABOUT 5 YEARS AND 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO FEELING TIGHTNESS AND A LIMITED RANGE OF MOTION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE PATELLA AND POLY (FROM 12MM TO 11MM). THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON THOUGHT THE PATELLA WAS UNDERSIZED, BUT THE CAUSE WAS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 18266622 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 1 MONTH 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 18181958 ↗
• InjuryJul 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS FROM 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17396714 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2010. ON (B)(6) 2020, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE PATELLA AND TIBIA. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, INSERT, AND PATELLA AND ADDED AN EXTENSION STEM AND CONE. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON OPENED THE PATIENT AND FOUND NO IMPLANTS TO BE LOOSE. HE REVISED THE POLY (WITH ONE OF THE SAME THICKNESS; NO INSTABILITY REPORTED) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17348647 ↗
• InjurySep 9, 2022Break; Break

  GMK SPHERE IMPLANTED APPROXIMATELY 6 YEARS AND 10 MONTHS AGO (12 AUG 2015) FOR OSTEOARTHRITIS. THE PATIENT PRESENTED WITH A PAINFUL KNEE, AND RADIOGRAPHS REVEALED THAT THE INSERT SCREW HAD BROKEN AND WAS LOOSE IN THE JOINT. THE SURGEON REMOVED THE PART OF THE SCREW LOOSE IN THE JOINT AND IMPLANTED A NEW INSERT (WITHOUT THE SCREW). ONLY HALF OF THE SCREW WAS RECOVERED, THE OTHER HALF IS STILL LODGED IN THE TIBIAL TRAY.

  Patient problems: Pain

  MAUDE report 15392133 ↗
• InjurySep 8, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION PERFORMED 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION. ONLY INSERT REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 15376910 ↗
• InjuryJul 18, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY AT ABOUT 1 YEAR AND 2 MONTHS POST PRIMARY FOR KNEE INSTABILITY. THE SURGEON EXPLANTED THE LINER THICK 12MM AND IMPLANTED A THICKER LINER OF 17MM.

  Patient problems: Joint Laxity

  MAUDE report 15037411 ↗
• InjuryJul 14, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING A STIFF KNEE. AT 5 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE 12MM POLY TO A 10MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 15011706 ↗
• InjuryJun 9, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 3 MONTHS AND A HALF AFTER THE PRIMARY, REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14641376 ↗
• InjuryApr 25, 2022Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT 1 YEAR AND 4 MONTHS POST PRIMARY THE SURGEON REVISED THE INSERT WITH A HIGHER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 14191937 ↗
• MalfunctionDec 22, 2021Migration; Migration

  INLAY LOCKING SCREW UNSCREWING, NO REVISION HAS BEEN PERFORMED AT THE MOMENT. PRIMARY WAS PERFORMED IN (B)(6) 2017.

  Patient problems: Failure of Implant

  MAUDE report 13058735 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED TO DO A WASH OUT OF AN INFECTED KNEE TWO WEEKS AFTER PRIMARY SURGERY. 18 DAYS AFTER PRIMARY SURGERY THE TIBIAL INSERT WAS EXPLANTED AND EXCHANGED WITH AN INSERT OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 12106248 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND THE CAUSE OF THE ANTERIOR KNEE PAIN IS UNKNOWN. 3 YEARS AND 5 MONTHS AFTER PRIMARY THE SURGERY RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12056289 ↗
• InjuryJun 23, 2021Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. 1 YEAR AND 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT - FLEX S4L - 12 MM WITH A GMK-SPHERE TIBIAL INSERT - FLEX S4R - 17MM TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12047794 ↗
• InjuryMay 27, 2021Appropriate Device Problem Term/Code Not Available

  18 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 11893144 ↗
• InjuryJan 14, 2021Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY, 2 YEARS 11 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED THE 12MM POLY WITH A 17MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11168792 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN (2 YEARS AND 9 MONTHS AFTER PRIMARY SURGERY) REPORTING PAIN AND IT WAS OBSERVED THAT THE PATIENT HAD DEVELOPED ARTHROFIBROSIS (FIBROTIC TISSUE AROUND THE JOINT) WHICH LIMITED THE PATIENT'S FLEXION. THE CAUSE OF THE ARTHROFIBROSIS IS UNKNOWN. THE SURGEON CLEANED THE FIBROTIC TISSUE AND DOWNSIZED THE SPHERE INSERT FLEX RIGHT 12MM S4 TO A SPHERE INSERT FLEX RIGHT 11MM S4 TO OPEN UP THE JOINT AND GIVE THE PATIENT MORE ROOM TO BEND THE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Fibrosis; Pain

  MAUDE report 11075683 ↗
• InjuryDec 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2019, THE PATIENT CAME IN COMPLAINING OF PAIN AND IT WAS OBSERVED THAT THE POLY HAD BECOME DISENGAGED, NO SCREW WAS USED. THE SURGEON REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY USING THE SCREW.

  Patient problems: Pain

  MAUDE report 9494236 ↗
• InjuryJul 3, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 9 MONTHS AFTER THE PRIMARY DUE TO KNEE STIFFNESS. THE SURGEON REVISED THE 12MM POLY WITH A 10 MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 8757900 ↗
• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem

  5 DAYS AFTER PRIMARY THE SURGEON PERFORMED A REVISION SURGERY OF THE KNEE FOR AN HEMATOMA. THE SURGEON PERFORMED AN I&D AND POLY-SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hematoma

  MAUDE report 8631628 ↗