GMK Sphere Total Knee System 02.12.0004LRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07630030825835), received between Aug 17, 2017 and Jan 14, 2026 — classified as 26 injuries.

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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO INSTABILITY AS THE RESULT OF EXCESSIVE KNEE VALGUS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TO A GMK-REVISION SYSTEM WITH AUGMENTATIONS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24068442 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT4 YEARS 11 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER, TIBIA, AND FEMUR TO HINGE TO GIVE THE PATIENT MORE STABILITY. NO ISSUE DETECTED ON THE LIGAMENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23615333 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 4 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING STIFFNESS, WHICH WAS ATTRIBUTED TO INADEQUATE REHABILITATION. THE SURGEON REVISED THE PATIENT TO A HINGE KNEE. DEBRIDEMENT OF THE TISSUES WAS PERFORMED TO REMOVE SCAR TISSUE AND ADDITIONAL BONE RESECTION WAS NECESSARY ACCOMMODATE THE SMALLEST HINGE POLY OF 12MM. SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 21207094 ↗
• InjuryOct 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT UNDERGONE PRIMARY SURGERY ON THE (B)(6) 2020 AND GMK-SPHERE COMPONENTS, WITHOUT PATELLA RESURFACING, HAVE BEEN IMPLANTED. ON THE (B)(6) 2022, THE PATIENT HAS BEEN REVISED BECAUSE OF ANTERIOR KNEE PAIN AND LOOSENING OF THE TIBIAL TRAY. THE SURGEON REVISED SUCCESSFULLY THE TIBIAL TRAY AND INSERT AND IMPLANTED A RESURFACING PATELLA SIZE 1. PRESENTLY, ON THE (B)(6) 2024, THE PATIENT HAS BEEN REVISED DUE TO PAIN. NO LOOSENING AND INFECTION DETECTED. THE SURGEON REMOVED FEMORAL AND TIBIAL COMPONENTS AND INSERT AND IMPLANTED GMK-REVISION SYSTEM.

  Patient problems: Implant Pain

  MAUDE report 20426111 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN IN THE KNEE. THE PATIENT HAD A MEDACTA SPHERE KNEE IMPLANTED ON (B)(6) 2023. IT IS UNKNOWN IF A REVISION SURGERY HAS BEEN DONE OR PLANNED.

  Patient problems: Implant Pain

  MAUDE report 20064726 ↗
• InjuryAug 26, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ON THE (B)(6) 2022, THE PATIENT UNDERGONE A PRIMARY SURGERY WITH IMPLANTATION OF GMK-SPHERE SYSTEM. ON THE (B)(6) 2024, THE PATIENT HAS BEEN REVISED FOR INFECTION AND THE INSERT HAS BEEN CHANGED (NO INFORMATION ON REF AND LOT). ON THE (B)(6) 2024, THE PATIENT HAS BEEN REVISED BECAUSE OF INFECTION. THE SURGEON REMOVED ALL THE COMPONENTS, PERFORMED A WASHOUT AND IMPLANTED A GMK-REVISION SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 20063780 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 1 YEAR AND 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING STIFFNESS, WHICH WAS CAUSED BY ARTHROFIBROSIS. THE SURGEON REVISED THE FEMORAL COMPONENT, POLY AND TIBIAL INSERT, CONVERTING THE SPHERE KNEE TO A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 19949041 ↗
• InjuryJul 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE INCORRECT SIZE COMBINATION HAS BEEN IMPLANTED DUE TO HUMAN ERROR (FEMUR SIZE 4 AND TIBIAL INSERT SIZE 3). THE PATIENT WAS ALREADY OUT OF THE ROOM WHEN THE DISCREPANCY WAS REALIZED SO THE REVISION SURGERY HAS BEEN PERFORMED THE NEXT DAY. FEMUR AND LINER WERE REVISED AND SPHERE FEMUR CEMENTED LEFT S3 + AND GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3L - 14MM SUCCESSFULLY IMPLANTED.

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

  MAUDE report 19699913 ↗
• InjuryDec 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  KNEE REVISION SURGERY DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH AND A HALF AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18254531 ↗
• InjuryNov 16, 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 3 YEARS AND 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON OPENED UP THE PATIENT AND OBSERVED THAT BOTH THE TIBIAL TRAY AND FEMORAL COMPONENT WERE LOOSE. THE CAUSE OF THE LOOSE IMPLANTS IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND POLY WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 18148921 ↗
• InjuryApr 14, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY AT ABOUT 4 YEARS AND 8 MONTHS POST PRIMARY DUE TO THE CEMENTED FEMUR AND TIBIA DEVICES LOOSENING. ALL DEVICES WERE SWAPPED SUCCESSFULLY. GRANULOMAS WERE PRESENT IN THE JOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743198 ↗
• InjuryMar 24, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON OBSERVED IN A CT SCAN THAT ALL THE COMPONENTS MAY BE LOOSE. ABOUT 6 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY (SPHERE SYSTEM IMPLANTED; LINER REVISED FROM 12MM TO 14MM).

  Patient problems: Pain

  MAUDE report 16611982 ↗
• InjuryNov 28, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 MONTH AND 3 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS, AND UPON EXAMINATION, THE PATIENT WAS UNABLE TO STRAIGHTEN TO FULL EXTENSION. THE SURGEON DECREASED THE POLY SIZE AND ALSO REVISED THE FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 15868553 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem

  MASSIVE PAIN IN THE KNEE (EVERYWHERE). NO INFECTION, NO IMPLANT LOOSENING. RADIOLOGICAL EXAM TO CALCULATE THE LONG AXIS: MAYBE A ROTATION'S DEFAULT. AT 8 MONTHS AFTER THE PRIMARY, EXPLANTATION OF THE FEMORAL COMPONENT TO CHANGE THE ROTATION (MORE VALGUS) - EXPLANTATION OF THE TIBIAL INSERT (PREVENTION).

  Patient problems: Pain

  MAUDE report 13505699 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED ABOUT 5 YEARS AFTER THE PRIMARY SURGERY DUE TO LOW-GRADE INFECTION. ALL IMPLANTS WERE REVISED. THE EXACT PRIMARY DATE IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12133386 ↗
• InjuryApr 23, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED 4 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY DUE TO DUE TO LEFT SITE TIBIAL TRAY SUBSIDENCE AND MOBILIZATION OF THE FEMORAL COMPONENT (THE PATIENT IS BILATERAL). THE RIGHT SIDE TIBIAL COMPONENT IS MOBILIZED AND WILL BE REVISED LATER (RIGHT KNEE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2017).

  Patient problems: Insufficient Information

  MAUDE report 11715542 ↗
• InjuryJul 8, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION, 11 MONTHS AFTER PRIMARY SURGERY, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10243565 ↗
• InjuryJun 17, 2020Inadequacy of Device Shape and/or Size; Improper or Incorrect Procedure or Method

  DURING THE SURGERY THE NURSE TAKEN FOR ERROR THE WRONG SIZES AND THE SURGEON IMPLANTED THEM. THE FIELD SPECIALIST DETECTED THE ERROR FEW HOURS AFTER SURGERY DURING A CHECK. NO REVISION SURGERY PLANNED AT THIS TIME FOR THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 10161718 ↗
• InjuryApr 7, 2020Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR. THE CAUSE OF THE LOOSE FEMUR IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, POLY, AND ADDED AN EXTENSION STEM 4 YEARS AND 3 MONTHS AFTER PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9932415 ↗
• InjuryApr 17, 2019Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2019 WE WERE INFORMED ABOUT A PATIENT WHO WOULD HAVE NEEDED A REVISION DUE TO PAIN AND SUSPECTED FEMORAL COMPONENT LOOSENING. THE REVISION WAS PERFORMED ON (B)(6) 2019: THE SURGEON REVISED THE FEMORAL COMPONENT (CONFIRMED TO BE LOOSE) AND POLY BUT DID NOT REVISE THE TIBIAL TRAY. THE POLY WAS REVISED ONLY FOR PROPHYLAXIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD A PRIMARY TKA ON (B)(6) 2015 AND HAD BEEN ALREADY REVISED DUE TO LAXITY ON (B)(6) 2018 (TIBIAL TRAY, FEMORAL COMPONENT AND POLY WERE REVISED - COMPLAINT (B)(4)).

  Patient problems: Joint Disorder

  MAUDE report 8522873 ↗
• InjuryMar 1, 2019Loose or Intermittent Connection

  REVISION SURGERY AFTER 2 MONTHS FROM THE PRIMARY DUE TO LOOSENING OF THE PROSTHESIS CAUSED BY INFECTION: EPIDERMAL STAPHYLOCOCCUS FOUND. LINER, FEMORAL AND TIBIAL COMPONENTS HAVE BEEN REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8381781 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED 9 MONTHS AFTER PRIMARY DUE TO INFECTION. PATHOGEN IS STREPTOCOCCUS ORALIS.

  Patient problems: Unspecified Infection

  MAUDE report 8217189 ↗
• InjuryAug 31, 2018Inadequacy of Device Shape and/or Size

  ON 01 AUGUST 2018 WE WERE INFORMED THA THE SURGEON PLANNED TO USE THE FEMORAL COMPONENT SIZE 4R, THE TIBIAL TRAY SIZE T3I4 AND THE TIBIAL INSERT SIZE 4 ORIGINALLY. AFTER THE SURGERY PERFORMED ON (B)(6) 2018, OUR SALES REP FOUND THAT THE TIBIAL TRAY AND TIBIAL INSERT WERE NOT USED AS PLANNED. NOBODY FOUND THIS EVENT DURING THE SURGERY. DUE TO THIS REASON THE REVISION SURGERY PLANNED FOR (B)(6) 2018. REVISION PERFORMED SUCCESSFULLY ON THE (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7837108 ↗
• InjuryJun 8, 2018Microbial Contamination of Device

  ABOUT 1 YEAR AFTER PRIMARY THE SURGEON REMOVED ALL THE PATIENT DEVICES AND IMPLANTED A SPACER FOR A HIP INFECTION. PATIENT POSITIVE TO STAPHYLOCOCCUS EPIDERMIDIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7582494 ↗
• InjuryMay 18, 2018Loose or Intermittent Connection

  REVISION OF TIBIAL BASEPLATE AND FEMORAL COMPONENT DUE TO LOOSENING 2 YEARS AND 3 MONTHS AFTER PRIMARY. IMPLANTS CAME OFF EASILY WITHOUT ANY BONE LOSS, THE SURGEON DECIDED TO REVISE BOTH IMPLANTS WITH GMK PRIMARY.

  Patient problems: Joint Disorder

  MAUDE report 7525806 ↗