GMK Sphere Total Knee System 02.12.0514FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07630030826825), received between Jan 19, 2018 and Dec 19, 2023 — classified as 11 injuries.

The most frequently reported specific device problem is “Unstable” (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.

• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE INSERT (FROM 14MM TO 20MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18355545 ↗
• InjuryJul 21, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15073935 ↗
• InjuryDec 7, 2021Appropriate Device Problem Term/Code Not Available

  AT 1 YEAR 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS DUE TO A FLEXION CONTRACTURE. THE CAUSE OF THE FLEXION CONTRACTURE IS UNKNOWN. THE SURGEON REVISED THE POLY (14 MM TO 13 MM) AND ALSO REVISED THE PATELLA TO BE MORE LATERAL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 12951285 ↗
• InjuryNov 11, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY 2 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT - FLEX S5R - 14 MM WITH A GMK-SPHERE TIBIAL INSERT - FLEX S5R - 17 MM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12795157 ↗
• InjuryMar 4, 2021Unstable

  REVISION SURGERY WAS INITIALLY PLANNED FOR (B)(6)2021, 11 MONTHS AFTER THE PRIMARY SURGERY. THE REASON IS INSTABILITY. THE SURGEON PLANNED TO USE A HIGHER INSERT AND TO RESURFACE PATELLA BONE. FINALLY, THE SURGERY WAS CANCELLED.

  Patient problems: Joint Laxity

  MAUDE report 11412241 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN WHICH WAS CAUSED BY A HEMATOMA. THE SURGEON PERFORMED A WASHOUT AND REVISED THE MEDACTA SPHERE INSERT FLEX RIGHT 14MM S5 WITH A MEDACTA SPHERE INSERT FLEX RIGHT 14MM S5 2 WEEKS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hematoma

  MAUDE report 9631687 ↗
• InjuryDec 6, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 3 MONTHS AFTER PRIMARY AND THE PATHOGEN IS UNKNOWN AT THIS TIME. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP.

  Patient problems: Unspecified Infection

  MAUDE report 8137070 ↗
• InjuryNov 23, 2018Adverse Event Without Identified Device or Use Problem

  ABOUT 1 YEAR AND 10 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR INLAY FIXATION SCREW UNSCREWING. LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 8099793 ↗
• InjuryNov 7, 2018Insufficient Device Problem Information

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND SWAPPED THE POLY 2 WEEKS AFTER PRIMARY SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 8045563 ↗
• InjurySep 5, 2018Fracture; Device Dislodged or Dislocated

  ABOUT 3 MONTHS AFTER PRIMARY SURGERY THE PATIENT WAS REVISED FOR KNEE DISLOCATION DUE TO PATELLA TENDON FRACTURE. ON (B)(6) 2018 THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE PATIENT WAS DISLOCATING. THE SURGEON REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 7845327 ↗
• InjuryJan 19, 2018Unstable

  ONE YEAR AND 1 MONTH AFTER PRIMARY THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. NO TRAUMA REPORTED. THE SURGEON REVISED SUCCESSFULLY A 14MM POLY FOR A 17MM.

  Patient problems: Joint Disorder

  MAUDE report 7206144 ↗