GMK Sphere Total Knee System 02.12.0023RRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07630030862380), received between Sep 8, 2017 and Jul 1, 2024 — classified as 23 injuries.

The most frequently reported specific device problem is “Unstable” (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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 5 YEARS AND 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMORAL COMPONENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMORAL IMPLANT AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 19641456 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 7 YEARS 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO HYPEREXTENSION OF THE KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR AND INSERT (10 TO 14 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18376013 ↗
• InjuryDec 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 YEARS AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS IDENTIFIED AS MRSA. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT, INSERT AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18301127 ↗
• InjuryJul 20, 2023Malposition of Device; Malposition of Device

  AT ABOUT 2 YEARS 3 MONTHS AFTER THE PRIMARY, REVISION SURGERY DUE TO FEMORAL ROTATION WITH A SIGNIFICANT VALGUS. ANTERIOR PAIN ALSO DESCRIBED BY THE PATIENT. NO IMPLANT LOOSENING. NO INFECTION. THE SURGEON REVISED SUCCESSFULLY THE FEMORAL COMPONENT AND THE TIBIAL INSERT AND PERFORMED THE RESURFACING OF PATIENT'S NATURAL PATELLA.

  Patient problems: Pain

  MAUDE report 17359568 ↗
• InjuryApr 28, 2023Malposition of Device; Malposition of Device

  AT ABOUT 1 YEAR AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN. THE SURGEON OBSERVED THAT THE FEMUR WAS TOO INTERNALLY ROTATED AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS ALSO NOTED THE DISLOCATION OF NATURAL PATELLA. THE NATURAL PATELLA WAS NOT RESURFACED.

  Patient problems: Pain

  MAUDE report 16831490 ↗
• InjuryMar 2, 2023Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  ABOUT 1 MONTH AND 10 DAYS AFTER PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A CAPSULE TEAR, DISLOCATED PATELLA IMPLANT, AND SUBSIDED FEMORAL COMPONENT. THE PATELLA DISLOCATED DUE TO THE CAPSULE TEAR AND SUBSIDENCE OF THE FEMORAL COMPONENT, WHICH CAUSED THE ROTATION TO BE OFF. THE SURGEON BELIEVES THIS HAPPENED BECAUSE THE PATIENT HAD A SOFT BONE. THE SURGEON REVISED ALL COMPONENTS TO REVISION SYSTEM (PATELLA IMPLANT NOT REVISED).

  Patient problems: Pain

  MAUDE report 16467869 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 7 MONTHS POST PRIMARY THE SURGEON REVISED ALL COMPONENTS WITH COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 14875363 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem

  1 YEAR AND 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT HAD A SECOND PROSTHESIS REVISION TOGETHER WITH PATELLAR TENDON RECONSTRUCTION. THE SURGEON THOUGHT THAT THE FEMORAL COMPONENT WAS SLIGHTLY INSIDE ROTATED AND THE PATIENT HAD PAIN. HINGE PROSTHESIS IMPLANTED.

  Patient problems: Pain

  MAUDE report 12467309 ↗
• InjuryMar 4, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 6 MONTHS AFTER THE PRIMARY FOR KNEE STIFFNESS. THE PATIENT HAD LIMITED PHYSICAL THERAPY DUE TO COVID-19. THE SURGEON REVISED FEMUR AND TIBIAL INSERT AND IMPLANTED A GMK REVISION FEMUR WITH STEM AND A SEMI CONSTRAINED INSERT.

  Patient problems: Loss of Range of Motion

  MAUDE report 11409233 ↗
• InjurySep 23, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE LINER AND FEMORAL COMPONENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10572820 ↗
• InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 1 YEAR AFTER PRIMARY SURGERY THE SURGEON REMOVED ALL COMPONENT'S AND IMPLANTED A MEDACTA FEMUR AND INSERT WITH ANTIBIOTIC CEMENT TO ACT AS A TEMPORARY SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10521605 ↗
• InjuryJul 10, 2020Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  2 YEARS AND 10 MONTHS AFTER PRIMARY THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE FEMORAL COMPONENT. 3 YEARS POST PRIMARY THE SURGEON REVISED THE FEMORAL COMPONENT AND POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10257287 ↗
• InjuryMar 25, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING STIFFNESS AND PAIN IN THE KNEE. THE CAUSE OF THE KNEE STIFFNESS AND PAIN IS PATELLA BAJA. 7 MONTHS AFTER PRIMARY SURGERY THE SURGEON REVISED SUCCESSFULLY THE KNEE SWAPPING THE FEMORAL AND TIBIAL COMPONENTS.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 9880470 ↗
• InjuryJan 24, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO INFECTION, DURING THE SURGERY IT WAS NOTICED THAT THE TIBIAL INSERT WAS DISENGAGED FROM THE TIBIAL TRAY. FIXATION SCREW WAS NOT USED IN PRIMARY SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 9627476 ↗
• InjuryDec 10, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED, ONE MONTH AFTER PRIMARY SURGERY, DUE TO INFECTION. ALL COMPONENTS HAVE BEEN SUCCESSFULLY REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 9443713 ↗
• InjuryMar 15, 2019Device Dislodged or Dislocated

  ON (B)(6) 2019 WE WERE INFORMED ABOUT A PATIENT WHO, 10 MONTHS AFTER TKA, CAME IN WITH PAIN AND SWELLING IN THE KNEE: X-RAYS SHOW PATELLA SUBLUXATION. THE ADDITIONAL SURGERY HAS BEEN PERFORMED ON (B)(6) WITH PATELLA RESURFACING AND MEDIAL PATELLA-FEMORAL LIGAMENT (MPFL) RECONSTRUCTION.

  Patient problems: Joint Swelling; Pain

  MAUDE report 8424798 ↗
• InjurySep 7, 2018Unstable

  ABOUT 10 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR KNEE INSTABILITY PROBABLY DUE TO A PREVIOUS PATELLAR TENDON INJURY.

  Patient problems: No Code Available

  MAUDE report 7854958 ↗
• InjuryAug 24, 2018Mechanics Altered

  THE PATIENT CAME IN COMPLAINING OF PAIN 1 YEAR AND 9 MONTHS AFTER PRIMARY: THE MCL HAD RUPTURED. POST MCL REPAIR THE SURGEON NOTICED THAT THE PATIENT PRESENTED WITH A VALGUS ALIGNMENT: HE RECUT THE FEMUR TO FIT A SIZE 3 GMK REVISION PS FEMUR AND REVISED ALSO INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 7812472 ↗
• InjuryMay 25, 2018Insufficient Device Problem Information

  ABOUT 1 YEAR AND 9 MONTH AFTER PRIMARY THE SURGEON REVISED THE PATIENT JOINT FOR A INFECTION. ALL THE DEVICES SWAPPED SUCCESSFULLY. THE PATHOGEN IS STAPHYLOCOCCUS

  Patient problems: Unspecified Infection

  MAUDE report 7544744 ↗
• InjuryApr 12, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 2 MONTHS AFTER THE PRIMARY. THE PATIENT WAS (B)(6) FOR (B)(6). THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7425014 ↗
• InjuryJan 17, 2018Insufficient Device Problem Information

  REVISION SURGERY 1 YEAR AFTER PRIMARY WAS NECESSARY DUE TO INFECTION. THE PATHOGEN RESULT IS NOT AVAILABLE. THE SURGEON REVISED ALL COMPONENTS AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7199218 ↗
• InjuryOct 12, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE PATIENT IS PRESENTING WITH LIGAMENTOUS INSTABILITY. THE CAUSE IS UNKNOWN. THE SURGEON IS REQUESTING A CUSTOM INSERT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2017.

  Patient problems: Joint Disorder

  MAUDE report 6944542 ↗
• InjurySep 8, 2017Unstable

  THE PATIENT CAME IN COMPLAINING OF PAIN AND INSTABILITY. THE CAUSE OF THE PAIN AND INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE 12MM INSERT WITH A 14MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6851187 ↗