GMK Sphere Total Knee System 02.12.0025LRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07630030862410), received between Apr 30, 2019 and May 30, 2025 — classified as 16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 8 YEARS AND 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22114074 ↗
• InjuryApr 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS AND 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY. DURING THE REVISION, THE SURGEON OBSERVED THAT THE FEMORAL COMPONENT WAS LOOSE DUE TO LACK OF CEMENT ADHERENCE. THE SURGEON REVISED THE FEMUR, INSERT AND PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21760519 ↗
• InjuryFeb 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY FOR KNEE LOOSENING AT ABOUT 6 YEARS AND 10 MONTHS POST-PRIMARY DUE TO FEMORAL LOOSENING. DURING THE REVISION, IT WAS FOUND THAT THE TIBIAL IMPLANT WAS LOOSE TOO. THERE WERE NO SIGNS OF CEMENT ON THE REVISED IMPLANTS.

  Patient problems: Aseptic loosening

  MAUDE report 21321420 ↗
• InjuryOct 28, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS AFTER THE PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF FEMORAL AND TIBIAL COMPONENTS MOBILIZATION. IT WAS REPORTED THAT THE PATIENT STARTED TO EXPERIENCE PROBLEMS IMMEDIATELY AFTER THE PRIMARY. DURING THE REVISION, THE FEMORAL IMPLANT CAME OFF IMMEDIATELY AND A LITTLE AMOUNT OF CEMENT REMAINED ON THE CONDYLE OF THE DEVICE. ALL IMPLANTS HAVE BEEN REVISED SUCCESSFULLY.

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

  MAUDE report 20545183 ↗
• InjuryMay 7, 2024Malposition of Device; Malposition of Device

  THE PATIENT CAME IN REPORTING PAIN AND REVISION SURGERY WAS PERFORMED AT ABOUT 5 MONTHS AFTER PRIMARY DUE TO THE FEMORAL COMPONENT MALPOSITIONING. PATIENT PRIMARY SURGERY WAS PERFORMED USING PATIENT SPECIFIC MYKNEE GUIDES AND, AT THE END OF THE SURGERY FROM THE POST-OP X-RAYS, IT WAS DETECTED THAT THE FEMORAL COMPONENT WAS IMPLANTED TOO MUCH IN FLEXION WITH RESPECT TO THE PLANNED CUT.

  Patient problems: Implant Pain

  MAUDE report 19257376 ↗
• InjuryOct 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY FOR INFECTION AT 1 YEAR AND 11 MONTHS POST PRIMARY AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17852274 ↗
• InjuryFeb 1, 2023Adverse 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 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS AND SWITCH TO A REVISION SYSTEM, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16276069 ↗
• InjuryJan 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING REHAB AT 4 MONTHS FROM PRIMARY, PATELLAR DISLOCATION WAS EXPERIENCED. FEMUR, PATELLA IMPLANT AND INSERT REVISED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16157251 ↗
• InjuryOct 24, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING AND THE CAUSE IS UNKNOWN. ABOUT 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS EXCEPT THE PATELLA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 15657369 ↗
• InjuryDec 13, 2021Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT 10 MONTHS AFTER THE PRIMARY SURGERY AND IT WAS DETERMINED THAT THE PATIENT NEEDED TO BE CONVERTED BECAUSE THE QUADRICEP WAS NOT STRONG ENOUGH AND WAS CAUSING THE KNEE TO HYPEREXTEND. ALL COMPONENTS WERE REVISED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12982990 ↗
• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem

  2 YEARS 3 MONTHS AFTER THE PRIMARY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS ESCHERICHIA COLI. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11847282 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN 1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11481956 ↗
• InjuryAug 27, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN AFTER 5 MONTHS FROM THE LAST REVISION SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL COMPONENTS AND IMPLANTED NEW COMPONENTS THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS PATIENT HAD 2 REVISION SURGERY PREVIOUSLY DUE TO AN INFECTION WHERE ONLY THE INSERT WAS SWAPPED (FOR BOTH CASES). THIS REVISION SURGERY HAPPENED 2 YEARS AND 7 MONTHS AFTER PRIMARY SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 10458489 ↗
• InjuryFeb 12, 2020Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 9698515 ↗
• InjuryNov 5, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 1 YEAR AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE FEMUR, TIBIA AND INSERT COMPONENTS AND IMPLANTED AN ARTICULATING SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9278377 ↗
• InjuryApr 30, 2019Microbial Contamination of Device

  ON APRIL 1ST WE WERE ALERTED OF A KNEE INFECTION, THE REVISION SURGERY WAS PERFORMED SUCCESSFULLY ON APRIL 3RD, ABOUT 1 YEAR AFTER PRIMARY. ALL HARDWARE WERE EXPLANTED AND AN ANTIBIOTIC SPACER WAS PUT IN. THE PATIENTS WAS FIRST NOTED TO HAVE AN INFECTION AT THE 4TH WEEK POST SURGERY. THE FIRST SWAB RESULTS CAME BACK AS A STAPH AUREUS INFECTION. THE PATIENT HAS HAD MULTIPLE SURGERIES SINCE TO WASH THE KNEE OUT AND TO TRY TO REMOVE THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8564993 ↗