GMK Sphere Total Knee System 02.12.0003LRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07630030825811), received between Oct 13, 2017 and Sep 10, 2025 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2016. ON (B)(6) 2021, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE TIBIAL INSERT SCREW HAD DISENGAGED AND ENDED UP INSIDE OF THE TISSUE. IT WAS ALSO OBSERVED THAT THE TIBIAL INSERT SCREW HAD CAUSED DAMAGE TO THE UNRESURFACED PATELLA. THE SURGEON REVISED THE LINER, TIBIAL TRAY AND ADDED AN EXTENSION STEM AND PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT REPORTING PAIN AFTER FALLING. THE SURGEON OBSERVED THAT THE PATIENT HAD A LOOSE AND SUBSIDED TIBIA. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETE SUCCESSFULLY. ON (B)(6), 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR AND INSERT (TO AN INSERT OF THE SAME SIZE, PER STANDARD PROCEDURE) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23014742 ↗
• InjuryJun 12, 2025Adverse 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 6 YEARS AND 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING LOOSENING OF TIBIAL AND FEMORAL COMPONENTS. MOREOVER, SUBSIDENCE OF THE FEMUR IS PRESENT. THE SURGEON REVISED ALL THE COMPONENTS TO GMK-HINGE SYSTEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 22192828 ↗
• InjuryMar 17, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 8 DAYS AFTER THE PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF LIGAMENT DAMAGE. THE CAUSES ARE UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE IMPLANTS AND IMPLANTED GMK HINGE WITH EXTENSION STEMS. NO ISSUES WITH THE IMPLANTS DETECTED.

  Patient problems: Damage to Ligament(s)

  MAUDE report 21618973 ↗
• InjuryMar 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS AND 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND THE CAUSE OF THE LOOSE FEMUR IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21535226 ↗
• MalfunctionApr 19, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  A FEMUR 3R WAS FOUND INSIDE A BOX LABELLED 3L. DURING THE SURGERY, THE SURGEON PUT THE FEMUR WITH CEMENT ON THE PATIENT BONE AND AS SOON AS POSITIONED RECOGNIZED THE ISSUE. A NEW FEMUR WAS OPENED AND IMPLANTED. THE SOFT CEMENT WAS REMOVED FROM BONE AND A NEW LEFT FEMUR WAS IMPLANTED. THERE WERE 10 MINUTES OF DELAY DUE TO THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19141610 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR KNEE LAXITY AT 6 YEARS AND 4 MONTHS POST PRIMARY. FEMUR AND LINER REVISED, GMK REVISION IMPLANTED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19070211 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A RUPTURED MCL THAT WAS CAUSED FROM TWISTING THE KNEE WHEN ENTERING A CAR. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 16563757 ↗
• InjuryNov 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL THE IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15867831 ↗
• InjuryNov 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 YEARS AFTER THE SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A KNEE LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO GMK REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 15778462 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN FROM A KNEE DISLOCATED. THE DISLOCATION WAS DUE TO A POSTERIOR CAPSULE RUPTURE THAT OCCURRED THE DAY AFTER THE PRIMARY SURGERY. AT ABOUT 3 DAYS AFTER THE PRIMARY, THE SURGEON CONVERTED THE PATIENT TO A HINGE KNEE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15444799 ↗
• InjuryJun 10, 2022Appropriate Device Problem Term/Code Not Available

  PATELLA LUXATION AND MEDIAL LIGAMENT INSTABILITY 8 MONTHS AFTER THE PRIMARY SURGERY. THE FEMORAL COMPONENT WAS CHANGED TO A GMK REVISION SC WITH STEM, DISTAL 4MM AUGMENT AND A SC INLAY.

  Patient problems: Insufficient Information

  MAUDE report 14652250 ↗
• InjuryJun 9, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT WITH A LOOSE KNEE AND OVERSTRETCHED MCL AND THE CAUSE IS UNKNOWN. AT 1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE FEMUR AND INSERT; ADDED SOME VARUS ALIGNMENT AND IMPLANTED A REVISION FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 14641596 ↗
• InjuryApr 26, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED DUE TO THE FEMORAL ROTATION WHICH LEFT THE PATIENT IN VALGUS. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT (1 YEAR AND 6 MONTHS AFTER THE PRIMARY), THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 14207481 ↗
• InjuryNov 25, 2021Appropriate Device Problem Term/Code Not Available

  AT 18 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT SUCCESSFULLY. AFTER THE PRIMARY SURGERY, THE PATIENT HAS VASCULAR SURGERY ON THE IMPLANTED LEG AND BECAME VERY UNSTABLE.

  Patient problems: Insufficient Information

  MAUDE report 12874307 ↗
• InjuryOct 14, 2021Loosening of Implant Not Related to Bone-Ingrowth

  4 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING LOOSENESS IN THE KNEE (LOOSE LIGAMENTS). THE SURGEON DECIDED TO CONVERT THE PATIENT TO A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 12631243 ↗
• InjurySep 3, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD RETROPATELLAR COMPLAINT. IT WAS FOUND THAT THE PATIENT HAD NICKEL ALLERGY. THE PRIMARY PROSTHESIS WAS WELL IMPLANTED. THE PATELLAR TENDONS WERE STUCK TOGETHER. BECAUSE OF THE ALLERGY, THE SURGEON REVISED ALL IMPLANTS 2 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12421320 ↗
• InjuryFeb 9, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN 1 YEAR AND 6 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11300310 ↗
• InjuryApr 15, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO SUBLUXATION OF THE PATELLA 1 YEAR AND 1 MONTH AFTER THE PRIMARY. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PROBLEM WITH THE PATELLA SUBLUXATION WAS PROBABLY DUE TO A MALROTATION OF THE FEMORAL COMPONENT.

  Patient problems: Joint Disorder

  MAUDE report 9961389 ↗
• InjuryJan 2, 2019Loose or Intermittent Connection

  REVISION SURGERY DUE TO PAIN AND INSTABILITY 4 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY. ALL THE COMPONENTS WERE REVISED.

  Patient problems: Pain

  MAUDE report 8208010 ↗
• InjuryAug 29, 2018Device Slipped; Malposition of Device

  THE SURGEON REMOVED THE IMPLANT DUE TO AN INFECTION 1 MONTHS AND HALF AFTER PRIMARY SURGERY. AFTER THAT HE IMPLANTED A SPACER. THE FINAL REVISION HAS NOT BEEN SCHEDULED YET. AFTER THE REMOVAL OF THE DEVICES, HE FOUND THAT THE EXPLANTED COMPONENT WERE NOT ADHERED COMPLETELY TO THE BONE CEMENT IN COMPARISON WITH THE COMPETITOR'S ONE. HE FELT THE ADHESION STRENGTH OF BONE CEMENT AND OUR DEVICES WERE TOO LOW. [(B)(6).]

  Patient problems: Unspecified Infection

  MAUDE report 7826827 ↗
• InjuryJun 8, 2018Malposition of Device; Torn Material

  REVISION SURGERY BECAUSE THE EXTENSOR MECHANISM (QUADRICEPS MUSCLE GROUP) WAS TORN AND IMPLANTS MOBILIZED.

  Patient problems: Joint Disorder

  MAUDE report 7582496 ↗
• InjuryOct 13, 2017Positioning Problem

  THE PATIENT UNDERWENT AN ADDITIONAL SURGERY ON (B)(6) 2017 BECAUSE THE FEMUR WAS MALROTATED. THE SURGEON REVISED THE FEMORAL COMPONENT AND THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 6947958 ↗