GMK Sphere Total Knee System 02.12.0311FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07630030862564), received between Aug 18, 2017 and Mar 22, 2024 — classified as 19 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED DUE TO DISSOCIATION OF THE INLAY FROM THE TIBIAL BASEPLATE 1 MONTH AFTER THE PRIMARY SURGERY. THE INLAY HAS BEEN REVISED.

  Patient problems: Joint Laxity

  MAUDE report 18957292 ↗
• InjuryMay 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2016. ON (B)(6) 2021, 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. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17031354 ↗
• InjuryApr 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 YEAR AND 10 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16785288 ↗
• InjuryNov 24, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN UNABLE TO GET FULL EXTENSION. AT ABOUT 1 YEAR AFTER PRIMARY THE SURGEON REVISED THE 11MM POLY WITH THE 10 MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15860520 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 8 MONTHS AFTER THE PRIMARY SURGERY, 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 13280394 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem

  AT 5 YEARS 4 MONTHS 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 12851080 ↗
• InjuryNov 9, 2021Appropriate Device Problem Term/Code Not Available

  AT 6 MONTHS AFTER THE PRIMARY THE PATIENT CAME IN REPORTING PAIN AND TIGHTNESS IN THE KNEE DUE TO SCAR TISSUE THAT HAD DEVELOPED. THE SURGEON CLEANED OUT THE SCAR TISSUE AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Scar Tissue

  MAUDE report 12777580 ↗
• InjuryMar 31, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO KNEE INSTABILITY.

  Patient problems: Insufficient Information

  MAUDE report 11594050 ↗
• InjuryJan 20, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN AFTER 1 MONTH FROM THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11200970 ↗
• InjurySep 22, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 7 MONTHS AFTER PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10567151 ↗
• InjuryJul 8, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 7 MONTHS AFTER THE PRIMARY SURGERY REPORTING LAXITY AND THE SURGEON REVISED THE POLY FROM 11MM TO 17MM. THE SURGERY WAS SUCCESSFUL.

  Patient problems: Joint Disorder

  MAUDE report 10243568 ↗
• InjuryJul 7, 2020Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE 11MM POLY WITH A 17MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10239484 ↗
• MalfunctionMay 29, 2020Unstable; Appropriate Device Problem Term/Code Not Available

  ABOUT 2 YEARS AFTER PRIMARY SURGERY THE SURGEON REVISED THE PATIENT KNEE FOR PAIN AND INSTABILITY. THE SURGEON RESURFACED THE PATELLA AND SWAPPED THE 11MM POLY WITH A 14MM ONE.

  Patient problems: Joint Disorder

  MAUDE report 10101052 ↗
• InjuryApr 17, 2020Detachment of Device or Device Component

  THE PATIENT CAME IN REPORTING PAIN DUE TO THE INSERT POPPING OUT OF ALIGNMENT 4 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE SPHERE INSERT FLEX LEFT 11MM S3 WITH A SPHERE INSERT FLEX LEFT 11MM S3. THE SURGERY WAS COMPLETED SUCCESSFULLY. DURING THE PRIMARY SURGERY, A TIBIAL INSERT SCREW WAS NOT UTILIZED.

  Patient problems: Pain

  MAUDE report 9971792 ↗
• InjuryMar 9, 2020Material Too Rigid or Stiff

  THE PATIENT CAME IN REPORTING DISCOMFORT DUE TO STIFFNESS IN THE KNEE. THE SURGEON REVISED THE MEDACTA SPHERE INSERT FLEX LEFT 11MM S3 WITH A MEDACTA SPHERE INSERT FLEX LEFT 10MM S3 13 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 9805224 ↗
• InjuryNov 28, 2018Insufficient Device Problem Information

  ABOUT 1 MONTH AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A HIP INFECTION. I&D PERFORMED AND LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8110188 ↗
• InjuryOct 18, 2018Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY 1 YEAR AND 3 MONTHS AFTER PRIMARY SURGERY. THE SURGEON REVISED THE 11MM LINER TO A 14MM LINER.

  Patient problems: No Code Available

  MAUDE report 7977296 ↗
• InjurySep 14, 2018Insufficient Device Problem Information

  REVISION SURGERY PERFORMED DUE TO INFECTION 9 DAYS AFTER PRIMARY. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY. THE PATHOGEN IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 7876584 ↗
• InjuryMay 18, 2018Contamination

  ABOUT 2 MONTH AFTER PRIMARY THE PATIENT WAS REVISED FOR A KNEE INFECTION. LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATHOGEN IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 7525817 ↗
• InjuryAug 18, 2017Insufficient Device Problem Information

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 6803611 ↗