GMK Sphere Total Knee System 02.12.0004RRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 07630030825842), received between Oct 12, 2017 and Mar 30, 2026 — classified as 29 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF A METAL ALLERGY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TO GMK-HINGE TINBN COATED SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology

  MAUDE report 24710794 ↗
• InjuryFeb 12, 2026Device Appears to Trigger Rejection

  REVISION SURGERY WAS PERFORMED 2 YEARS AND 4 MONTHS AFTER THE PRIMARY PROCEDURE DUE TO A NICKEL ALLERGY, WHICH RESULTED IN JOINT STIFFNESS. THE SURGEON REVISED THE GMK SPHERE FEMORAL COMPONENT, TRAY, AND INSERT WITH TINBN-COATED COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology

  MAUDE report 24321117 ↗
• InjuryJul 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEAR AND 4 MONTHS FORM THE PRIMARY SURGERY, THE PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF ALL COMPONENTS. NO INFECTION DETECTED. THE SURGERY WAS CONCLUDED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541064 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE PAIN AND STIFFNESS AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 3 MONTHS POST PRIMARY THE SURGEON REVISED THE PATIENT TO A HINGE KNEE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21411260 ↗
• InjuryNov 20, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION DUE TO OF INFECTION AT ABOUT 1 YEAR AND 6 MONTHS POST PRIMARY. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND IMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20735104 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING LAXITY OF THE KNEE AND THE CAUSE IS UNKNOWN. AT ABOUT 4 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE FEMUR (WITH A POSTERIOR STABILIZED REVISION FEMORAL COMPONENT) AND INSERT (FROM 14MM TO 17MM AND SEMI CONSTRAINED). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20555190 ↗
• InjurySep 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY FOR KNEE PAIN AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 8 MONTHS POST PRIMARY THE SURGEON REVISED THE FEMUR, INSERT AND TIBIA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20200990 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AT ABOUT 4 YEARS AND 11 MONTHS FOR KNEE INSTABILITY. FEMUR AND TIBIAL INSERT REVISED SUCCESSFULLY. NO INFECTION OR DEVICE LOOSENING WAS DETECTED.

  Patient problems: Joint Laxity

  MAUDE report 17442900 ↗
• InjuryFeb 22, 2023Malposition of Device; Malposition of Device

  THE PATIENT HAD A SEVERELY VALGUS JOINT LINE. THE ATTEMPT TO CORRECT THE LEG AXIS IN A STABLE WAY WITH A HIGHER INLAY (10 TO 20 MM) FAILED. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 16417087 ↗
• InjuryJul 22, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 6 YEARS FROM THE PRIMARY SURGERY, IT WAS DISCOVERED THE LOOSENING OF FEMORAL AND TIBIAL IMPLANTS. FEMUR, LINER AND TIBIA WERE REMOVED AND A REVISION PROSTHESIS WAS PUT IN PLACE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15083015 ↗
• InjuryJul 13, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14998485 ↗
• InjuryJul 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  TIBIAL TRAY SUBSIDENCE AND FEMORAL LOOSENING IN THE KNEE. REVISION SURGERY PERFORMED AT ABOUT 1 YEAR AND A HALF POST PRIMARY.

  Patient problems: Insufficient Information

  MAUDE report 14945400 ↗
• InjuryMay 27, 2022Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMORAL COMPONENT AND TIBIAL TRAY. ABOUT 3 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE MEDACTA FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT WITH COMPETITOR PRODUCTS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14521545 ↗
• InjuryMay 10, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  AT 4 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON OBSERVED THAT THE COMPONENTS WERE LOOSE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14346312 ↗
• MalfunctionJan 25, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  DURING THE PRIMARY KNEE SURGERY AND AFTER CEMENTING THE FEMORAL COMPONENT, THE IMPLANT FELL OFF THE FEMUR. THE SURGEON STATED IT WAS UNUSUAL BEHAVIOR FOR THE CEMENT AND IT WAS NOTICED ON 2 FOLLOWING CASES AFTER THIS ONE. THIS CAUSED AN HOUR DELAY IN THE CASE DUE TO THE HARDENED CEMENT HAVING TO BE REMOVED. THE SAME FEMORAL COMPONENT WAS USED TO COMPLETE SUCCESSFULLY THE CASE. THE CEMENT USED WAS NOT A MEDACTA PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13340923 ↗
• InjuryDec 14, 2021Unstable

  AT 3 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND HYPEREXTENSION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER AND FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON USED A THICKER LINER TO PROVIDE GREATER VARUS/VALGUS STABILITY AND REVISING THE FEMORAL COMPONENT TO GIVE THE PATIENT A POST TO REDUCE HYPEREXTENSION.

  Patient problems: Joint Laxity

  MAUDE report 13001323 ↗
• InjuryAug 5, 2021Appropriate Device Problem Term/Code Not Available

  1 MONTH AFTER THE PRIMARY THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR AND THE CAUSE OF THE FRACTURED FEMUR IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 12280952 ↗
• InjuryJul 19, 2021Malposition of Device; Malposition of Device

  2 DAYS AFTER THE PRIMARY THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON OBSERVED THAT THE PATIENT WAS IN EXCESSIVE VALGUS. THE SURGEON REVISED THE FEMORAL COMPONENT, PATELLA, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12187885 ↗
• InjuryJul 21, 2020Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 10300534 ↗
• InjurySep 20, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN COMPLAINING OF LIMITED RANGE OF MOTION AFTER ABOUT 4 YEARS. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 9097723 ↗
• InjuryMar 6, 2019Loose or Intermittent Connection; Unstable

  REVISION SURGERY PERFORMED, 2 YEARS AFTER PRIMARY SURGERY, DUE TO INSTABILITY CAUSED BY A LOOSE FEMORAL COMPONENT. THE FEMORAL COMPONENT, TIBIAL TRAY AND TIBIAL INSERT HAVE BEEN REVISED.

  Patient problems: Joint Disorder

  MAUDE report 8394716 ↗
• InjuryFeb 21, 2019Loose or Intermittent Connection; Inadequacy of Device Shape and/or Size

  DURING THE PRIMARY KNEE SURGERY AND WHILE TRIALING FOR THE POLY, IT WAS DISCOVERED THAT THE CEMENT DID NOT ADHERE TO THE SIZE 4 FEMORAL COMPONENT AND THE IMPLANT WAS LOOSE. THE SURGEON REMOVED THE FEMORAL COMPONENT AND REMOVED THE CEMENT FROM THE PATIENT'S FEMUR WITH A BUR. THIS CAUSED A 45 MINUTE DELAY IN THE CASE. THE SURGEON IMPLANTED A DIFFERENT SIZE 4 FEMORAL COMPONENT AND HAD NO ISSUES WITH THE CEMENT ADHERING TO THE IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CEMENT WAS NOT A MEDACTA PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8357665 ↗
• InjuryDec 19, 2018Insufficient Device Problem Information

  THE PATIENT HAD A PRIMARY TOTAL KNEE SURGERY ON (B)(6) 2017. THE PATIENT NOW REPORTS THAT SHE IS EXPERIENCING PAIN AND DISCOMFORT THAT CAUSES HER TO BE UNABLE TO WALK, 4 MONTHS AFTER PRIMARY. NO ADDITIONAL DETAILS ARE AVAILABLE.

  Patient problems: Pain

  MAUDE report 8178703 ↗
• InjuryOct 17, 2018Malposition of Device

  ABOUT 1 YEAR AFTER PRIMARY SURGERY THE SURGEON REVISED THE PATIENT KNEE FOR FEMUR AND TIBIAL TRAY MAL POSITIONING DURING PRIMARY. ALL HARDWARE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7973279 ↗
• InjuryJul 19, 2018Loose or Intermittent Connection

  PATIENT PRESENTED WITH PATELLA FEMORAL PAIN 4 YEARS AFTER PRIMARY [NO PATELLA RESURFACING COMPLETED IN PRIMARY CASE]. SURGEON PLANNED TO RESURFACE THE PATELLA AND REVISE THE LINER, BUT DURING SURGERY THE FEMORAL COMPONENT WAS FOUND LOOSE (IT CAME OFF VERY EASILY), SO IT WAS REPLACED WITH A NEW ONE, SAME SIZE 4 SPHERE. IN ADDITION, A NEW 12MM POLY AND A INSET PATELLA SIZE 24 WERE IMPLANTED.

  Patient problems: Pain

  MAUDE report 7702520 ↗