GMK Sphere Total Knee System 02.12.0006LRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030825873), received between Aug 3, 2017 and Sep 6, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A TIBIAL SUBSIDENCE. THE CAUSE OF THE TIBIAL SUBSIDENCE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY, INSERT, AND IMPLANTED TIBIAL AUGMENTS, AN OFFSET CONNECTOR, AND A FLUTED EXTENSION STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 20155190 ↗
• InjuryMay 24, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  KNEE REVISION SURGERY AT ABOT 2 YEARS AND 8 MONTHS POST PRIMARY DUE TO INFECTION. ALL DEVICES REVISED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19389771 ↗
• InjuryDec 7, 2023Malposition of Device; Malposition of Device

  THE PATIENT HAD A PRIMARY KINEMATIC TOTAL KNEE ARTHROPLASTY TKA ON (B)(6) 2023. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN FOLLOWING A TRAUMATIC EVENT FROM JUMPING INTO A POOL THAT CAUSED A PATELLA DISLOCATION. ON (B)(6) 2023, THE SURGEON PERFORMED A RELEASE OF SOFT TISSUE AND SUTURED TO FORCE THE PATELLA MORE MEDIAL. NO IMPLANTS WERE REVISED. PRESENTLY, THE PATIENT CAME IN REPORTING PAIN IN THE KNEE.THE PATIENT WAS STILL HAVING PATELLA ALIGNMENT ISSUES SO THE SURGEON DECIDED TO REVISE THE PATIENT TO REPOSITION THE FEMUR FOR BETTER PATELLA TRACKING. THE SURGEON REVISED THE FEMORAL COMPONENT, INSERT AND TIBIAL TRAY SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18281306 ↗
• InjuryDec 21, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN. THE XRAYS INDICATED THAT THE IMPLANTS WERE LOOSE. AT ABOUT 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY, DURING REVISION SURGERY, THE SURGEON NOTED FEMUR AND TIBIA WERE ABLE TO BE REMOVED WITH MILD TO MODERATE DISTRACTION FORCE. THE SURGEON REVISED THE FEMUR, TIBIA, AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. REVISION SYSTEM IMPLANTED.

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

  MAUDE report 16023348 ↗
• InjurySep 16, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018. ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION. ON (B)(6) 2021, THE PATIENT WAS REVISED FOR THE SECOND TIME FOR ASEPTIC TIBIAL LOOSENING. PRESENTLY, ON (B)(6) 2022, THE PATIENT WAS REVISED FOR THE THIRD TIME BECAUSE OF INFECTION. THE SURGEON PERFORMED A SINGLE STAGE REVISION AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15438884 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 14021282 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING STIFFNESS DURING FLEXION. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND POLY 1 YEAR 6 MONTHS AFTER THE PRIMARY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 12015486 ↗
• InjuryNov 24, 2020Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 10895939 ↗
• InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. 4 YEARS AND 2 MONTHS AFTER PRIMARY THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10822487 ↗
• InjuryOct 24, 2018Loss of or Failure to Bond

  THE PATIENT CAME IN COMPLAINING OF PAIN AND STIFFNESS. THE SURGEON OPENED THE PATIENT AND NOTICED THAT THE CEMENT DID NOT ADHERE TO THE IMPLANTS. THE TYPE OF CEMENT USED IS PALACOS R. THEY WERE ABLE TO POP OFF THE FEMUR AND TIBIA COMPONENTS WITH ESSENTIALLY NO EFFORT. NONE OF THE CEMENT STUCK TO THE COMPONENTS. THE SURGEON REMOVED THE FEMUR, INSERT AND TIBIA AND REPLACED IT WITH ANOTHER COMPANY'S PRODUCT.

  Patient problems: Pain

  MAUDE report 7999370 ↗
• InjuryJun 25, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY ON (B)(6) 2016. ON (B)(6) 2017 THE PATIENT CAME IN DUE TO SIGNS OF INFECTION [PATHOGEN NOT AVAILABLE]. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY. (MDR 2017-00602) ON (B)(6) 2018 THE PATIENT WAS REVISED AGAIN. THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. PATHOGEN UNKNOWN. THE SURGEON PULLED ALL HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7634070 ↗
• InjuryAug 3, 2017Appropriate Device Problem Term/Code Not Available

  THE PATIENT COMPLAINED KNEE PAIN AND HAS A FLEXION DEFICIT. THE SURGEON HAS PLANNED A REVISION SURGERY ((B)(6) 2017) FEW MONTHS AFTER PRIMARY TO CHANGE THE PATIENT'S FEMUR AND INLAY.

  Patient problems: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 6763279 ↗