GMK Sphere Total Knee System 02.12.0025RRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07630030862427), received between Aug 17, 2017 and May 15, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS AND 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE FEMORAL COMPONENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT, FEMUR AND PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 22027589 ↗
• InjuryOct 31, 2024Loosening 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) 2018. ON (B)(6) 2021, 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, TIBIAL TRAY, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT WITH SEVERE OSTEOLYSIS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR, TIBIA AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20576910 ↗
• InjuryDec 20, 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 3 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 18364383 ↗
• InjuryDec 7, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ABOUT 2 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING AN INABILITY TO ACHIEVE FULL EXTENSION. THE SURGEON'S PLAN WAS TO DO A FULL REVISION, BUT WHEN HE OPENED UP THE PATIENT, HE SAW THAT THE FEMUR CAME RIGHT OUT AND THAT THE TIBIA WAS WELL FIXED. HE HAD ALREADY STARTED PREPPING THE PATIENT FOR A SIZE 5 BECAUSE THE REVISION SIZES DO NOT HAVE A "5+". HE THEN SAID HE WASN'T GOING TO DO THE FULL REVISION AND JUST REVISE THE PATIENT WITH A NEW FEMUR AND INSERT. SINCE HE ALREADY PREPPED FOR THE SIZE 5 FEMUR HE PUT IN A SIZE 5 FEMUR. THE INSERT WAS REVISED PER STANDARD PROCEDURE. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18281394 ↗
• InjuryApr 18, 2023Failure to Osseointegrate; Failure to Osseointegrate

  THE PATIENT CAME IN REPORTING KNEE PAIN DUE TO ALL IMPLANTS BEING LOOSE AND THE CAUSE OF THE LOOSE IMPLANTS IS UNKNOWN. ABOUT 6 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16761594 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS. THE SURGEON HAD PLANNED TO JUST PERFORM A POLY SWAP BUT INTRAOPERATIVELY FOUND THE PATIENT HAD A FLEXION CONTRACTURE. THE SURGEON THEN OPTED TO REVISE THE FEMUR AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN WHAT CAUSED THE FLEXION CONTRACTURE AFTER ORIGINAL SURGERY. PATIENT PRESENTED TO CLINIC WITH A STIFF KNEE AND REVISION WAS DETERMINED TO BE THE BEST OUTCOME. REVISION SYSTEM IMPLANTED.

  Patient problems: Loss of Range of Motion

  MAUDE report 16655187 ↗
• InjuryOct 27, 2022Device 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 2 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT AND FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15679055 ↗
• InjuryAug 24, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 10 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS, PERFORMED A WASHOUT, AND REIMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15282570 ↗
• InjuryAug 3, 2022Improper or Incorrect Procedure or Method; Appropriate Device Problem Term/Code Not Available

  AFTER THE PRIMARY LEFT KNEE SURGERY OCCURRED ON (B)(6) 2022, THE POST-OP X-RAYS SHOWED THAT RIGHT KNEE IMPLANTS WERE IMPLANTED IN THE PATIENT INSTEAD OF LEFT KNEE IMPLANTS. THE SURGEON REVISED SUCCESSFULLY THE PATIENT ON (B)(6) 2022, WITH THE CORRECT LEFT SIDE IMPLANTS.

  Patient problems: Insufficient Information

  MAUDE report 15154694 ↗
• InjuryJul 6, 2022Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, THE PATIENT CAME IN 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. ON (B)(6) 2022, THE SURGEON REMOVED THE FEMUR AND INSERT THAT WAS IMPLANTED TO ACT AS A SPACER AND IMPLANTED A NEW FEMUR AND INSERT WITH ANTIBIOTIC CEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14927440 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 8 MONTHS FROM PRIMARY, THE SURGEON PLANNED TO REMOVE ALL COMPONENTS AND IMPLANT AN ANTIBIOTIC SPACER; HOWEVER, THE SURGEON COULD NOT IMPLANT A SPACER DUE TO THE PRESENCE OF SCAR TISSUE AND THE TIGHTNESS OF THE KNEE. THE PATIENT CURRENTLY HAS NO IMPLANTS IN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14753805 ↗
• InjuryDec 11, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO INFECTION, 1 YEAR AFTER PRIMARY. ALL HARDWARE HAS BEEN REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 9449585 ↗
• InjuryAug 29, 2018Unstable

  WE WERE INFORMED ON (B)(6) 2018 THAT THE PATIENT CAME IN COMPLAINING OF ANTERIOR KNEE PAIN AND SLIGHT INSTABILITY. THE SURGEON PLANS TO REVISE THE PATIENT ON (B)(6) 2018. UPDATE (B)(6) 2018: THE SURGEON REVISED THE LINER AND RESURFACED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Arthralgia; Failure of Implant

  MAUDE report 7826844 ↗
• InjuryAug 17, 2017Contamination

  THE PATIENT CAME IN DUE TO SIGN OF INFECTION. THE PATIENT WAS POSITIVE FOR STREP. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED A SPACER ON AN UNKNOWN DATE. ON (B)(6) 2017 THE SURGEON REMOVED THE SPACER AND IMPLANTED PERMANENT MEDACTA PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 6800100 ↗