GMK Sphere Total Knee System 02.12.0212FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07630030826177), received between Aug 25, 2017 and Jul 24, 2025 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  AFTER CEMENTING THE TIBIAL TRAY AND FEMORAL COMPONENT TO THE BONE AND THOROUGHLY IRRIGATING THE SITE, THE SURGEON ATTEMPTED TO MANUALLY ENGAGE THE INSERT MULTIPLE TIMES BUT THE ATTEMPTS WERE UNSUCCESSFUL. THE SURGEON CONFIRMED THERE WERE NO FOREIGN MATERIALS ON THE TIBIAL TRAY AND CLEANED IT AGAIN. SINCE MANUAL INSERTION WAS NOT SUCCESSFUL, THE SURGEON USED AN IMPACTOR (REF. 02.07.4721), BUT THE INSERT STILL DID NOT ENGAGE PROPERLY. A SAME SIZE INSERT (REF. 02.12.0212FL, LOT 2340847) WAS IMPLANTED, AND THE SURGERY COMPLETED SUCCESSFULLY. THE TOTAL SURGERY TIME WAS 1.5 HOURS, AND THE DELAY TIME WAS 20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585411 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING STIFFNESS. THE SURGEON PERFORMED A WASHOUT, REVISED THE POLY (12 TO 10MM) AND RESURFACED THE PATIENT'S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 20899854 ↗
• InjuryNov 15, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 4 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON UPSIZED THE INSERT (FROM 12 MM TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18139901 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 YEARS 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (12 TO 20MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17276776 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 2 MONTHS AFTER THE PRIMARY, REVISION SURGERY FOLLOWING LAXITY OF THE LEFT KNEE. NO INFECTION. NO LOOSENING OF THE IMPLANTS. NO PAIN DESCRIBED BY THE PATIENT. THE SURGEON REVISED SUCCESSFULLY THE LINER (12MM TO 17MM) AND RESURFACED THE NATURAL PATELLA.

  Patient problems: Joint Laxity

  MAUDE report 16378504 ↗
• InjuryMar 2, 2021Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT REPORTED WORSENING ANTERIOR KNEE PAIN AND IT WAS PLANNED TO RESURFACE THE PATELLA BONE WITH THE IMPLANT. PATELLA WAS RESURFACED AFTER 6 YEARS AND 7 MONTHS FROM THE PRIMARY SURGERY AND LINER WAS REPLACED WITH A 1MM LARGER LINER DUE TO SOME LAXITY.

  Patient problems: Joint Laxity

  MAUDE report 11398277 ↗
• MalfunctionJul 23, 2019Difficult to Insert; Difficult to Insert

  DURING THE PRIMARY KNEE SURGERY AND WHILE ATTEMPTING TO ENGAGE THE INSERT SCREW INTO THE TIBIAL TRAY, THE SURGEON OBSERVED THAT THE SCREW WOULD NOT ENGAGE WITH THE TIBIAL TRAY. THE SURGEON USED ANOTHER 12MM S2 SPHERE INSERT TO COMPLETE THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8815009 ↗
• InjuryMar 22, 2019Unstable

  THE PATIENT CAME IN COMPLAINING OF PAIN 7 MONTHS AFTER THE PRIMARY SURGERY, THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON PERFORMED A SYNOVECTOMY TO ADDRESS THE PAIN, THE PATIENT ALSO PRESENTED WITH MID-FLEXION INSTABILITY AND THE SURGEON REVISED THE 12MM POLY WITH A 14MM POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8443627 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED TWO WEEKS AFTER PRIMARY SURGERY DUE TO SIGNS OF INFECTION. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY.

  Patient problems: Unspecified Infection

  MAUDE report 7946598 ↗
• InjuryMay 24, 2018Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 7540705 ↗
• InjuryAug 25, 2017Device Operates Differently Than Expected

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE PAIN WAS CAUSED BY SOFT TISSUE INSTABILITY. THE SURGEON REVISED THE INSERT. THE NEW LINER IMPLANTED WAS 2 MM THICKER THAN THE ONE EXPLANTED (14 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6819957 ↗