GMK Sphere Total Knee System 02.12.0410FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 07630030826535), received between Aug 3, 2017 and May 29, 2026 — classified as 88 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (19 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 90 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Migration

  REVISION SURGERY WAS PERFORMED DUE TO SCREW LOOSENING IN THE SURGICALLY REPAIRED KNEE, WHICH WAS OBSERVED FOLLOWING A FALL APPROXIMATELY 9 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REMOVED THE SCREW AND REVISED THE FLEX LEFT 10MM S4 INSERT TO A FLEX 4L - 12MM INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 25328465 ↗
• InjuryMay 12, 2026Device Appears to Trigger Rejection

  REVISION SURGERY AT ABOUT 1 YEAR AND 8 MONTHS POST PRIMARY THE SURGEON REVISED THE PATIENT FOR INFECTION. LINER REVISED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25148939 ↗
• InjuryApr 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION (B)(6) AFTER PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND I&D AND REVISED THE 10MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24826096 ↗
• InjuryMar 10, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION 2 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE SIZE 4 10MM LINER TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24558208 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 2 YEARS AND 9 MONTHS DUE TOKNEE INSTABILITY, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT FROM A 10 MM TO A A 13 MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24321123 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY (10 TO 12 MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22620673 ↗
• InjuryJul 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAS AN INFECTION IN THE LEFT KNEE JOINT. THE PRIMARY CASE WAS DONE ON (B)(6) 2022. THE SURGEON SUSPECTED THAT AN INFECTION FROM ELSEWHERE HAD MIGRATED THROUGH THE BODY AND PLANTED IN THE JOINT AS SCANS PICKED UP HIGH CELLULAR ACTIVITY IN THE LEFT KNEE JOINT, BUT THIS IS NOT CONFIRMED BECAUSE THE SPECIMEN RESULTS ARE STILL NOT AVAILABLE. ON THE (B)(6) 2025 THE LINER WAS REMOVED, JOINT WASHED OUT AND SAME LINER WAS PUT BACK IN. THE SURGEON ALREADY KNEW THAT A NEW REVISION WOULD BE NECESSARY IN A FEW DAYS AND FOR THIS REASON REIMPLANTED THE SAME LINER. ON THE (B)(6) 2025 THE SURGEON PERFORMED A SECOND SURGERY FOR INFECTION. THE SURGEON REVISED THE LINER FROM A 10MM TO AN 11MM AS THE KNEE FELT A LITTLE LOOSE, BUT THERE WERE NO SIGNS OF KNEE INSTABILITY BEFORE THE SURGERY.

  Patient problems: Medical device site infection

  MAUDE report 22540566 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO KNEE INSTABILITY PERFORMED ABOUT 4 YEARS AFTER THE PRIMARY SURGERY. LINER WAS REVISED FROM 10MM TO 14MM. THE SURGERY WAS FINISHED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22384186 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. AT 1 YEAR AND 9 MONTHS POST PRIMARY THE SURGEON REVISED UPSIZED THE POLY (FROM 10 TO 14 MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22130918 ↗
• InjuryFeb 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 7 YEARS 8 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21355584 ↗
• InjuryFeb 11, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 YEAR 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (10 TO 12 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21354413 ↗
• InjuryDec 3, 2024Device Appears to Trigger Rejection; Loosening of Implant Not Related to Bone-Ingrowth; Device Appears to Trigger Rejection; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO INFECTION AND LOOSENING. PRIMARY SURGERY DATE UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20832758 ↗
• InjuryNov 5, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR 3 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20610022 ↗
• InjuryMay 24, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 2 YEARS 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: Unspecified Infection

  MAUDE report 19390099 ↗
• InjuryMay 6, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT 1 YEAR 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: Unspecified Infection

  MAUDE report 19249218 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AFTER THE PRIMARY, THE PATIENT DESCRIBES A FEELING OF INSTABILITY ESPECIALLY WHEN GOING DOWN THE STAIRS. NO PAIN REPORTED. THE SURGEON NOTES A KNEE LAXITY IN FLEXION AND EXTENTION, HE DECIDED TO REVISE THE LINER (10 MM TO 14 MM).

  Patient problems: Joint Laxity

  MAUDE report 19153875 ↗
• InjuryMar 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD A PRIMARY TOTAL KNEE REPLACEMENT ON (B)(6) 2020. ON (B)(6) 2022 REVISION SURGERY FOR SUSPECTED TIBIAL TRAY LOOSENING DUE TO INFECTION. ONLY THE LINER WAS REVISED. NO FURTHER INFORMATION IS AVAILABLE. ON THE (B)(6) 2023 REVISION SURGERY FOR TIBIAL TRAY, FEMORAL IMPLANTS LOOSENING AND KNEE INSTABILITY. TIBIAL TRAY, TIBIAL STEM, FEMUR AND LINER REVISED SUCCESSFULLY. A 2 MM THICKER LINER HAS BEEN IMPLANTED. PATELLA IMPLANT NOT REVISED. DURING THE REVISION SOME TISSUES WERE TAKEN FOR SEPTIC TESTS. THE TEST RESULTS WERE NEGATIVE; NO INFECTION WAS DETECTED.

  Patient problems: Joint Laxity

  MAUDE report 18948317 ↗
• InjuryMar 14, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  KNEE REVISION SURGERY ON THE LEFT SIDE PERFORMED AT ABOUT 1 YEAR 11 MONTHS AFTER THE PRIMARY. LIGAMENTAL INSTABILITY ON THE INTERNAL PART AND PATIENT DISSATISFACTION WITH PAIN SINCE THE PRIMARY SURGERY. LOOSENING OF THE FEMORAL COMPONENT FOUND DURING THE REVISION SURGERY, NO LOOSENING OF THE TIBIAL PLATE. NO INFECTION. EXPLANTATION OF ALL THE COMPONENTS AND IMPLANTATION OF COMPETITOR REVISION IMPLANTS.

  Patient problems: Joint Laxity

  MAUDE report 18904426 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 7 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A RUPTURED EXTENSOR MECHANISM, WHICH OCCURRED DURING PHYSICAL THERAPY. THE SURGEON REPAIRED THE RUPTURED EXTENSOR MECHANISM AND REVISED THE 10MM INSERT WITH A 14MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Tissue Breakdown

  MAUDE report 18335148 ↗
• InjuryOct 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY FOR INFECTION AT 20 DAYS POST PRIMARY. THE SURGEON REVISED THE LINER SUCCESSFULLY (WITH ONE OF THE SAME SIZE).

  Patient problems: Medical device site infection

  MAUDE report 17904446 ↗
• InjuryOct 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 YEAR AND 8 MONTHS FROM THE PRIMARY, KNEE REVISION SURGERY ON THE LEFT SIDE DUE TO INFECTION. NO LOOSENING OF THE IMPLANTS. EXPLANTATION OF THE TIBIAL INSERT AND REIMPLANTATION OF A NEW ONE.

  Patient problems: Medical device site infection

  MAUDE report 17904253 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO INSTABILITY. THE SURGEON UPSIZED THE INSERT (FROM 10 MM TO 13 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17867048 ↗
• InjurySep 29, 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. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17841900 ↗
• InjuryAug 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISE THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17649307 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND SWELLING. NO ISSUES WITH THE IMPLANTS HAVE BEEN DETECTED. THE SURGEON REVISED THE LINER (SAME THICKNESS OF 10MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 17457530 ↗