GMK Sphere Total Knee System 02.12.0510FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 07630030826733), received between Oct 20, 2017 and Jun 26, 2026 — classified as 67 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (11 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 68 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Device Appears to Trigger Rejection

  REVISION SURGERY AFTER 4 YEARS AND 1 MONTH DUE TO INFECTION WITH THE PATHOGEN BEING STAPHYLOCOCCUS. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 10M FLEX S5L INSERT TO A 12MM FLEX 5L INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25632989 ↗
• InjuryMay 26, 2026Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FLEX S5L - 10 MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25275473 ↗
• InjuryFeb 19, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 2 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE LINER (11MM TO 13MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21408528 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY WAS UNKNOWN. THE SURGEON UPSIZED THE INSERT (FROM 10 TO 13 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19606503 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR FROM PRIMARY THE SURGEON REVISED THE LINER, IMPLANTING A THICKER ONE (FROM 10 TO 14 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19465865 ↗
• InjuryMay 24, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ON (B)(6) 2022, THE PATIENT UNDERWENT KNEE PRIMARY SURGERY. IMPLANTATION OF GMK-SPHERE FEMORAL COMPONENT 7 - TIBIAL INSERT 5 10MM - TIBIAL TRAY 5, WITHOUT RESURFACING PATELLA. ON (B)(6) 2024, THE PATIENT UNDERWENT THE FIRST REVISION SURGERY DUE TO ANTERIOR PAIN. PATELLA BONE RESURFACING PERFORMED AND RESURFACING PATELLA SIZE 4 IMPLANTED SUCCESSFULLY. NO ISSUES WERE DETECTED WITH THE OTHER GMK SPHERE DEVICES IMPLANTED IN THE PATIENT'S KNEE. ON (B)(6) 2024, THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO INFECTION CAUSED BY STAPHYLOCOCCUS AUREUS. WASHING OF THE KNEE, EXPLANTATION OF THE TIBIAL INSERT (PREVENTION) AND REIMPLANTATION OF A NEW ONE WITH THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 19390103 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE INSERT (10 TO 20 MM) AND ALSO DECIDED TO RESURFACE THE PATIENT'S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18940463 ↗
• InjuryNov 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY FOR A KNEE INFECTION AT 1 YEAR AND 11 MONTHS POST PRIMARY. THE SURGEON REVISED THE LINER SUCCESSFULLY. THE PATHOGEN IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 18158251 ↗
• InjuryOct 4, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIA AND THE INSERT (FROM 10MM TO 20MM ) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17868926 ↗
• InjuryOct 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS AND 9 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 17852169 ↗
• InjuryAug 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY AT ABOUT 2 YEARS AND 4 MONTHS POST PRIMARY FOR INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17659802 ↗
• InjuryJul 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 MONTHS AND A HALF 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17361647 ↗
• InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. ABOUT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT (FROM 10 MM TO 13 MM)AND RESURFACED THE PATIENT'S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16769102 ↗
• InjuryJan 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 WEEKS AFTER THE PRIMARY, REVISION SURGERY PERFORMED DUE TO INFECTION. THE SURGEON REVISED SUCCESSFULLY THE LINER (SAME SIZE).

  Patient problems: Medical device site infection

  MAUDE report 16156631 ↗
• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. ABOUT 5 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE 10MM POLY WITH A 14MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16067301 ↗
• InjuryNov 11, 2022Device 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 3 YEARS AND 4 MONTHS 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 15778664 ↗
• InjurySep 9, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION PERFORMED 2 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY DUE TO INFECTION. ONLY INSERT REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 15392101 ↗
• InjuryAug 30, 2022Device 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 MONTH FROM PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMUR AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15320141 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 YEAR AND 5 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 15147155 ↗
• InjuryJan 27, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2019. SUBSEQUENTLY, ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PATELLA PAIN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA. NO IMPLANTS REVISED. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 13365846 ↗
• InjuryJan 12, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AT ABOUT 1 MONTH AFTER PRIMARY DUE TO INFECTION. THE LINER WAS SWAPPED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13236220 ↗
• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem

  AT 2 WEEKS AFTER THE PRIMARY SURGERY, 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 13078030 ↗
• InjuryDec 14, 2021Appropriate Device Problem Term/Code Not Available

  AT 3 WEEKS AFTER THE PRIMARY SURGERY, 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 13001101 ↗
• InjuryDec 9, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH 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 12968472 ↗
• InjuryNov 25, 2021Appropriate Device Problem Term/Code Not Available

  AT 1 MONTH AFTER THE PRIMARY SURGERY, 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 12874315 ↗