GMK Sphere Total Knee System 02.12.0412FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07630030826573), received between Jul 27, 2017 and May 27, 2026 — classified as 33 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (7 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 YEAR AND 5 MONTHS FROM PRIMARY RIGHT KNEE SURGERY AND AFTER ABOUT 3 YEARS AND 5 MONTHS FROM LEFT KNEE SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LEFT KNEE`S FLEX S4L - 12 MM INSERT TO A FLEX 4L - 14MM INSERT. THE SURGEON ALSO REVISED THE RIGHT KNEE`S SIZE4 - 17 MM INSERT TO A SIZE4 - 20MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25297703 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  PRIMARY SURGERY PERFORMED ON THE (B)(6) 2020. IMPLANTATION OF GMK-SPHERE COMPONENTS WITHOUT PATELLA RESURFACING. REVISION SURGERY PERFORMED ON THE (B)(6) 2020 DUE TO ANTERIOR PAIN DESCRIBED BY THE PATIENT AND LAXITY OF THE KNEE. IMPLANTATION OF A RESURFACING PATELLA SIZE 2. 12MMLINER REVISED WITHA 14MM LINER. EVENT ALSO RELATED TO MDR (B)(4).

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 24603545 ↗
• InjuryJan 12, 2026Device Appears to Trigger Rejection

  AT ABOUT 3 YEARS AND 8 MONTHS FROM 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24031941 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS AND 1 MONTH AFTER THE PRIMARY THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE LINER (FROM 12MM TO 17MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23510669 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 2 YEARS 9 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON UPSIZED THE POLY (FROM 12 TO 20 MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22411001 ↗
• InjuryMay 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 9 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22114521 ↗
• InjuryJun 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO LAXITY THAT CAUSED KNEE INSTABILITY AFTER 3 YEARS AND 2 MONTHS FROM THE LAST REVISION SURGERY (MDR 3005180920-2021-00334). THE SURGEON REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19605705 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA AND KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT (12 TO 20 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 18246116 ↗
• InjuryAug 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 YEARS AND 7 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 SUCCESSFULLY THE LINER.

  Patient problems: Unspecified Infection

  MAUDE report 17457535 ↗
• InjuryMar 29, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. AT 11 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16634598 ↗
• InjuryJan 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16223190 ↗
• InjuryAug 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND DUE TO SIGNS OF AN INFECTION. THE REASON FOR THE INSTABILITY AND PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-SPHERE TIBIAL INSERT (12 MM TO 13MM TO IMPROVE THE STABILITY KNEE IN PER-OP). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15273673 ↗
• InjuryApr 29, 2022Material Too Rigid or Stiff

  REVISION SURGERY WAS PERFORMED 6 MONTHS AFTER THE PRIMARY DUE TO TIGHTNESS IN THE KNEE. THE SURGEON REVISED SUCCESSFULLY THE INSERT (12MM TO 10 MM).

  Patient problems: Loss of Range of Motion

  MAUDE report 14249026 ↗
• InjuryFeb 10, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT 1 YEAR AND 10 MONTHS AFTER THE PRIMARY, THE SURGEON REVISED THE INSERT AND PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 13504469 ↗
• InjuryNov 2, 2021Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. ABOUT 2 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT WITH A HIGHER ONE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12736480 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 4 YEARS 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 12467901 ↗
• InjuryAug 3, 2021Unstable

  1 YEAR AND 2 MONTHS AFTER THE PRIMARY THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT - FLEX S4L - 12 MM WITH A GMK-SPHERE TIBIAL INSERT - FLEX S4L - 17MM AND ALSO REVISED THE PATIENT'S NATURAL PATELLA SINCE THE PATELLA WAS THIN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 12266799 ↗
• InjuryJun 22, 2021Appropriate Device Problem Term/Code Not Available

  23 DAYS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO SUSTAINING A QUADRICEPS STRAIN. THE CAUSE OF THE DEVELOPMENT OF THE QUADRICEPS STRAIN IS UNKNOWN. THE SURGEON SUTURED THE PATIENT'S QUADRICEPS AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Tissue Breakdown

  MAUDE report 12038960 ↗
• InjuryApr 6, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 1 MONTH AND 9 DAYS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11618375 ↗
• InjuryMar 23, 2021Unstable

  THE PATIENT CAME IN 4 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT TO A THICKER INSERT TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11548805 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem

  1 MONTH AFTER THE PREVIOUS REVISION SURGERY THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED MEDACTA FEMUR AND TIBIA WITH ANTIBIOTIC CEMENT TO ACT AS A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11271431 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 1 MONTH AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11154580 ↗
• InjuryJun 2, 2020Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 10108747 ↗
• InjuryDec 5, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 3 MONTHS AFTER THE PRIMARY DUE TO SIGNS OF ACUTE INFECTION. THE SURGEON PERFORMED WASHOUT AND REVISED THE LINER.

  Patient problems: Unspecified Infection

  MAUDE report 9416217 ↗
• InjuryNov 11, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP 1 MONTH AND 3 WEEKS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9304123 ↗