GMK Sphere Total Knee System 02.12.0413FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030862632), received between Sep 25, 2018 and Feb 16, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AT 3 YEARS AND 3 MONTHS POST-PRIMARY DUE TOINSTABILITY OF UNKNOWN CAUSE. THE SURGEON REVISED THE INSERT FROM 13MM TO 16MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24343887 ↗
• MalfunctionNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS AND 1 MONTH POST PRIMARY, THE PATIENT REPORTS KNEE PAIN, SWELLING UNDER THE PATELLA, AND STIFFNESS AFTER SITTING OR IN THE MORNING, BUT NO NIGHT PAIN. PATIENT EXAM ((B)(6) 2025): MILD MEDIAL-LATERAL LAXITY (MORE IN FLEXION), NO ANTERIOR LAXITY, IMPLANT STABLE, PATELLA TRACKING CENTRALLY. ON (B)(6) 2025 THE COMPLAINT NOTIFIER REPORTED: NO INFECTION OR IMPLANT LOOSENING; LAXITY LIKELY DUE TO INTENSE ACTIVITY STRETCHING LIGAMENTS. REVISION SURGERY PERFORMED ON (B)(6) 2026, SIZE 16 CUSTOM LINER IMPLANTED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23615352 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY, NO INFORMATION ON THE PRIMARY SURGERY IS AVAILABLE. THE SURGEON REVISED TO A THICKER POLY, 13MM TO 20MM, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22529150 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS AND 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (13MM) WITH A THICKER ONE (17MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21695571 ↗
• InjuryApr 11, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO THE POLY DISENGAGING FROM THE TIBIAL TRAY AS THE PATIENT WAS GOING UP AND DOWNSTAIRS. PRIMARY PERFORMED IN (B)(6) 2021. THE SURGEON REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14072426 ↗
• InjuryOct 29, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 3 DAYS AFTER PRIMARY SURGERY, DUE TO SIGNS OF 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 10754892 ↗
• InjuryJul 15, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE POLY 19 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10275099 ↗
• InjuryDec 27, 2019Fracture

  REVISION SURGERY PERFORMED 7 MONTHS AFTER THE PRIMARY DUE TO PAIN DUE TO A FRACTURED LATERAL PORTION OF THE PATELLA. THE SURGEON LEFT THE ORIGINAL PATELLA IN AND TRIMMED OFF THE DAMAGED PORTION AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 9523157 ↗
• InjurySep 27, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 2 WEEKS AFTER PRIMARY SURGERY, FOR A FOLLOW-UP APPOINTMENT AND POST-OP X-RAYS WERE TAKEN. THE POST-OP X-RAYS INDICATED THAT THE POLY-INSERT WAS NOT SEATED AND LOCKED INTO THE BASEPLATE. THE SURGEON REVISED THE MEDACTA SPHERE INSERT FLEX RIGHT 13 MM S4 WITH A MEDACTA SPHERE INSERT FLEX RIGHT 13 MM S4. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9128853 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE SPHERE INSERT FLEX RIGHT 13MM S4 WITH A MEDACTA SPHERE INSERT FLEX RIGHT 13MM S4 POLY ALMOST 9 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9085568 ↗
• InjuryApr 3, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 2 YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR KNEE INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8478393 ↗
• InjurySep 25, 2018Fracture

  THE PATIENT HAD A PRIMARY KNEE ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT FELL AND FRACTURED HER LATERAL TIBIAL PLATEAU. THE SURGEON REVISED THE INSERT AND TIBIAL TRAY . ON (B)(6) 2018 THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7905415 ↗