GMK Sphere Total Knee System 02.12.0414FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07630030826610), received between Oct 6, 2017 and May 12, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (1 report).

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING ANTERIOR KNEE PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE PATIENT`S NATURAL PATELLA AND REVISED THE 14MM INSERT TO 17MM INSERT TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25148963 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2017. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN AND DUE TO A FRACTURED PATELLA BONE THAT WAS CAUSED FROM FALLING. THE SURGEON REPAIRED THE PATELLA BONE, REVISED THE PATELLA IMPLANT AND DECIDED TO UPSIZE THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PATELLA PAIN. THE SURGEON PERFORMED A PATELLECTOMY AND UPSIZED THE POLY DUE TO KNEE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19032008 ↗
• MalfunctionOct 4, 2023Positioning Failure; Positioning Failure

  DURING REVISION SURGERY, THE SURGEON PERFORMED 14MM INSERT TRIAL AND ATTEMPTED TO INSERT A 14MM INSERT, BUT IT WOULD NOT FIT. A 13MM INSERT WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE DELAY TIME IS 50MIN AND THE TOTAL SURGERY TIME IS 2HR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868423 ↗
• InjuryNov 11, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND DIFFICULTY AMBULATING AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT'S POLY ON THE LEFT AND RIGHT KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15778446 ↗
• InjuryFeb 10, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT 2 YEARS AND 3 MONTHS FROM THE PRIMARY THE SURGEON REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANTED INSERT: 02.12.0417FL GMK-SPHERE TIBIAL INSERT - FLEX S4L - 17MM.

  Patient problems: Joint Laxity

  MAUDE report 13504672 ↗
• InjuryOct 11, 2021Unstable

  1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT - FLEX S4L - 14 MM WITH A GMK-SPHERE TIBIAL INSERT - FLEX S4L - 20MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12603765 ↗
• InjurySep 29, 2021Migration; Migration

  THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON TOOK X-RAYS THAT REVEALED THAT THE SCREW FROM THE TIBIAL INSERT HAD BACKED OUT. THE SURGEON REMOVED THE BACKED-OUT SCREW AND REVISED THE POLY AND TIBIA 4 YEARS AND 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12545489 ↗
• InjuryApr 13, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING TIGHTNESS IN THE KNEE AND THE CAUSE OF THE TIGHTNESS IS UNKNOWN. THE SURGEON REVISED THE INSERT WITH A 13MM ONE ALMOST 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 11654723 ↗
• InjuryJul 28, 2020Appropriate Device Problem Term/Code Not Available

  5 MONTHS AFTER THE PREVIOUS REVISION SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED A MEDACTA FEMUR AND INSERT WITH ANTIBIOTIC CEMENT AS AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10331236 ↗
• InjuryJul 14, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE 14MM POLY WITH A 17MM POLY AND REVISED THE TIBIAL TRAY 1 YEAR AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10270749 ↗
• InjuryMar 26, 2020Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking

  THE PATIENT CAME IN REPORTING PAIN DUE TO STIFFNESS IN THE KNEE. THE SURGEON REVISED THE 14MM INSERT WITH A 13MM INSERT ALMOST 2 YEARS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9882637 ↗
• InjuryMar 16, 2020Appropriate Device Problem Term/Code Not Available

  THE PATENT CAME IN 1 YEAR AND 4 MONTHS AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PLANS TO PERFORM A WASHOUT AND REVISE THE INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 9835283 ↗
• InjuryFeb 21, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 22 DAYS AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND INSERT-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9738052 ↗
• InjuryFeb 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT CAME IN FOR A CHECK-UP APPOINTMENT 3 YEARS AND 2 MONTHS AFTER THE PRIMARY. THE POLY DISLOCATED FROM THE TIBIAL TRAY. AS SHOWN IN THE X-RAYS, THE KNEE LOOKED MALIGNED, IMPROPERLY ORIENTED, AND MECHANICALLY UNSTABLE. EVERYTHING WAS REVISED WITH A GMK-HINGE SYSTEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 9738043 ↗
• InjuryOct 23, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, ONE MONTH AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN 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 9222729 ↗
• InjuryJun 14, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY (WASHOUT AND POLY SWAP) HAS BEEN PERFORMED ON (B)(4) 2018, 5 MONTHS FROM THE PRIMARY DUE TO AN INFECTION (THE PATHOGEN UNKNOWN, THE COMPLAINT: (B)(4), MDR: 2018-00330 WAS FILED). PRESENTLY THE SECOND REVISION SURGERY HAS BEEN PERFORMED AFTER 1 YEAR AND 1 MONTH FROM THE LAST REVISION DUE TO AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON REVISED THE FEMORAL COMPONENT AND THE INLAY AND IMPLANTED ANTIBIOTIC BEADS.

  Patient problems: Unspecified Infection

  MAUDE report 8699596 ↗
• InjuryApr 2, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED, 7 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND LINER SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8473638 ↗
• InjuryJul 18, 2018Malposition of Device

  ABOUT 3 YEARS AND A HALF AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE TIBIAL COMPONENTS FOR KNEE TIGHTNESS IN FLEXION/EXTENSION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 7698437 ↗
• InjuryOct 20, 2017Contamination

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON PERFORMED AN I&D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 6965051 ↗
• InjuryOct 6, 2017Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 6921429 ↗