GMK Sphere Total Knee System 02.12.0310FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 07630030826344), received between Sep 29, 2017 and May 15, 2026 — classified as 66 injuries.

The most frequently reported specific device problem is “Unstable” (9 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 66 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN PRESENTING ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON NOTED A PATIENT BMI OF 40. THE SURGEON REVISED THE PATIENT`S FLEX S3R - 10MM INSERT TO A 12MM INSERT AT HIS DISCRETION AND REVISED THE PATIENT`S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25185344 ↗
• InjuryAug 5, 2025Adverse 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 2 YEARS AND 3 MONTHS POST PRIMARY, THE SURGEON UPSIZED THE POLY THICKNESS IMPLANTING A 13MM TO INCREASE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22715392 ↗
• InjuryMay 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A TKA ON (B)(6) 2024 WITH AN INITIALLY GOOD COURSE. DURING A FOLLOW UP PERFORMED IN (B)(6) 2025, UNREMARKABLE FINDINGS HAVE BEEN FOUND. SUBSEQUENTLY, IN (B)(6) 2025, THE PATIENT PRESENTED A PAINFUL TOOTH AND LOCAL INFECTION IN THE JAW. FOLLOWING THIS, ON (B)(6) 2025, THE PATIENT DEVELOPED ACUTE SYMPTOMS WITH LOCAL SWELLING AND OVERHEATING. EMERGENCY CONSULTATION WAS PERFORMED ON (B)(6) 2025 AND IT HAS BEEN DIAGNOSED AN ACUTE HEMATOGENOUS LATE INFECTION. ON THE (B)(6) 2025, THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT WITH INSERT EXCHANGE. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22096084 ↗
• InjuryMay 13, 2025Device 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 7 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22010833 ↗
• InjuryMar 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION AT ABOUT 5 YEARS AND 9 MONTHS POST PRIMARY DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMUR AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21523848 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (10 TO 14 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21322114 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING KNEE 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 20862488 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION ABOUT 1 YEAR AND 5 MONTHS POST-PRIMARY DUE TO INSTABILITY. A 2MM THICKER LINER WAS IMPLANTED AND THE PATELLA BONE RESURFACED. WEAK MEDIAL RETINACULUM (SOFT TISSUE) MAY INFLUENCED THE STABILITY AS WELL. THE SURGEON COMMENTED THAT SOME ROTATION DEFECTS OF THE FEMORAL COMPONENT MAY BE PRESENT, BUT NOT CONFIRMED.

  Patient problems: Joint Laxity

  MAUDE report 20469806 ↗
• InjuryAug 22, 2024Migration; Migration

  THE PATIENT HAD KNEE PAIN, DUE TO LAXITY. BEFORE EXPLANTING THE 10MM INSERT, THE SURGEON OBSERVED THAT THE INSERT SCREW HAD DISASSOCIATED FROM THE IMPLANT AND MIGRATED TO THE POSTERIOR CAPSULE. AT ABOUT 6 YEARS AND 10 MONTHS POST PRIMARY THE SURGEON REMOVED THE SCREW AND REVISED THE 10MM SPHERE POLY WITH A 14MM E-CROSS POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE AGENT WAS UNABLE TO CONFIRM WHETHER THE TORQUE LIMITING SCREWDRIVER WAS UTILIZED IN THE PRIMARY SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20036219 ↗
• InjuryJul 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  KNEE PRIMARY SURGERY CONDUCTED USING KA TECHNIQUE ON (B)(6) 2024. ABOUT 2 MONTHS POST PRIMARY THE FEMORAL COMPONENT WAS DISLOCATED POSTERIORLY. THE CAUSE MIGHT BE DUE TO LIGAMENT LAXITY. THE PATIENT FREQUENTLY EXPERIENCED KNEE BUCKLING WHILE WALKING AND VISITED THE HOSPITAL. DURING THE PRIMARY SURGERY, THE BONE RESECTION AMOUNT AND THE TENSION DURING THE TRIAL WERE SATISFACTORY, SO THE SURGEON IS CONCERNED THAT THE LOOSENING MAY BE DUE TO THE PATIENT'S ACTIVITY. THE REVISION SURGERY WAS DONE ON (B)(6) 2024. THE 10MM INSERT WAS REPLACED WITH A 17MM INSERT AT THE REVISION SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 19708272 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR PAIN IN THE RIGHT KNEE AND REDUCED RANGE OF MOTION (ROM). AT 1 YEAR AND 10 MONTHS POST PRIMARY, SWITCH OF THE TIBIAL INSERT WITH A NEW E-CROSS LINER OF THE SAME THICKNESS AND RESURFACING OF PATELLA BONE. THE SURGEON TRIED TO REMOVE SOME TISSUE MAINLY AROUND THE POSTERIOR CONDYLES OF THE FEMUR, "CLEANED" AS MUCH AS POSSIBLE AND THE ROM WAS SLIGHTLY IMPROVED.

  Patient problems: Loss of Range of Motion

  MAUDE report 19048913 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AND 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE LINER (10MM) WITH A THICKER ONE (14MM).

  Patient problems: Joint Laxity

  MAUDE report 18966886 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON UPSIZED THE INSERT (FROM 10MM TO 12MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18482241 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF PAIN IS UNKNOWN. ABOUT 5 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE POLY FROM 10MM TO 11MM TO HELP WITH SOME INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18281184 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (FROM 10 MM TO 14 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18272887 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 8 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17964827 ↗
• InjurySep 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. ABOUT 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT (FROM 10 TO 14 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17825075 ↗
• InjuryJul 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 1 YEAR 5 MONTHS AFTER THE PRIMARY DUE TO SIGNIFICANT KNEE STIFFNESS WITH MAXIMUM FLEXION AT 20 DEGREES. ANTERIOR PAIN DESCRIBED BY THE PATIENT. NO IMPLANT LOOSENING. NO INFECTIONS. THE SURGEON REVISED SUCCESSFULLY GMK-SPHERE SYSTEM TO GMK-REVISION AND RESURFACED THE NATURAL PATELLA.

  Patient problems: Loss of Range of Motion

  MAUDE report 17388489 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO POOR PATELLA TRACKING AND LAXITY AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE PATELLA AND POLY (10 TO 11 MM) AND IMPLANTED A NEW SPHERIKA FEMORAL COMPONENT BECAUSE HE BELIEVES THAT THE NEW SPHERIKA FEMUR WILL HELP WITH THE PATELLA TRACKING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17377795 ↗
• InjuryJul 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO CEMENTED TIBIAL TRAY LOOSENING AND LAXITY, AT ABOUT 5 YEARS AND 3 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT (10 TO 17 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17369812 ↗
• InjuryJun 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  TWO 10MM LINERS (STANDARD PE) COULD NOT BE PLACED INTO THE THE TIBIAL TRAY. SINCE THE CEMENT WAS NOT HARD YET, AND THE ORIGIN OF THE PROBLEM WAS UNKNOWN, THE TIBIAL TRAY WAS EXPLANTED AND A NEW ONE WAS PLACED. THE SURGERY WAS COMPLETED USING A 11MM LINER (OTHER 10 MM LINERS WERE NOT AVAILABLE). 15 MINUTES DELAY OCCURRED. FEMUR WAS NOT IN PLACE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17077534 ↗
• InjuryMar 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A WOUND DEHISCENCE AFTER ABOUT 3 WEEKS FROM THE PRIMARY. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Wound Dehiscence

  MAUDE report 16596966 ↗
• InjuryJan 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE POLY (FROM 10 MM TO 12 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16232174 ↗
• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PATELLA PAIN AND THE CAUSE IS UNKNOWN. AT 8 YEARS AND 8 MONTHS POST PRIMARY THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15779696 ↗
• InjuryOct 27, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 11 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 ALL COMPONENTS TO REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 15680271 ↗