GMK Sphere Total Knee System 02.12.0003RRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07630030825828), received between Dec 28, 2017 and May 13, 2026 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 9 YEARS AND 7 MONTHS DUE TO PERSISTENT INSTABILITY. INTRAOPERATIVE FINDINGS REVEALED NO EVIDENCE OF IMPLANT LOOSENING OR INFECTION, AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE SURGEON REVISED ALL MEDACTA IMPLANTS.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25160332 ↗
• MalfunctionMar 14, 2025Malposition of Device; Malposition of Device

  PATIENT WAS OPERATED WITH GMK-SPHERE SYSTEM. DURING THE SURGERY, NEXTAR AND MYKNEE GUIDES WERE USED. PREOPERATIVELY SHE HAD A VARUS LEG AXIS, POSTOPERATIVELY SHE IS NOW VERY VALGUS. THE PATIENT IS IN REHABILITATION AND SHE IS DOING QUITE WELL. NO REVISION IS PLANNED. THE PATIENT IS MORE THAN 120 KG. THE SURGEON DID NOT PERFORM ANY FURTHER CUTS AFTER THE LAST SAVED CUTS ON NEXTAR PLATFORM. PATIENT'S LIGAMENTS CONDITION WAS VERY CRITICAL; THE PATIENT HAD A PREOPERATIVE STRETCH DEFICIT. THE VALGUS CONDITION WAS NOT NOTED INTRA-OPERATIVELY BECAUSE THE PATIENT HAD A VERY BIG SOFT TISSUE THEREFORE IT WAS NOT POSSIBLE TO SEE THE HKA AXIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604280 ↗
• InjurySep 11, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO TIBAIL AND FEMORAL LOOSENING AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL IMPLANTS TO REVISION COMPONENTS AND THE SURGERY WAS COMPLETE SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17717642 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  KNEE REVISION SURGERY PERFORMED ABOUT 2 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY. ANTERIOR PAIN DESCRIBED BY THE PATIENT AND INSTABILITY. NO INFECTION. NO LOOSENING OF THE IMPLANTS. THE SURGEON REVISED ALL COMPONENTS AND SWITCH TO REVISION SYSTEM WITH EXTENSION STEMS AND RESURFACED PATIENT'S NATURAL PATELLA.

  Patient problems: Pain

  MAUDE report 16805596 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 11 MONTHS AFTER THE PRIMARY SURGERY, PAIN WAS REPORTED BY THE PATIENT WITH SIGNIFICANT LIMITED FLEXION (IMPOSSIBILITY FOR THE PATIENT TO BEND THE LEG BEYOND 30 DEGREES). THE SURGEON LIFTED THE ANTERIOR TIBIAL TUBEROSITY TO ACCESS THE PROSTHESIS AND REVISED SUCCESSFULLY THE FEMORAL COMPONENT SIZE 3 WITH SIZE 2 AND TIBIAL INSERT (SAME SIZE).

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 16672282 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15409150 ↗
• InjurySep 6, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL IMPLANTS EXCEPT THE PATELLA, AND RE-IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15361268 ↗
• InjuryMar 2, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 7 MONTHS FROM TKR THE SURGEON PERFORMED A REVISION FOR A LIGAMENT RUPTURE (COLLATERAL LIGAMENT). THE SURGERY WAS COMPLETED SUCCESSFULLY REVISING THE FEMORAL AND TIBIAL COMPONENTS.

  Patient problems: Damage to Ligament(s)

  MAUDE report 13652428 ↗
• InjuryDec 3, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING TIGHTNESS IN THE KNEE AND THE CAUSE OF THE TIGHTNESS IS UNKNOWN. THE SURGEON REVISED THE LINER (WITH A LOWER ONE) AND THE FEMORAL COMPONENT ABOUT 1 YEAR AFTER THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE FEMORAL COMPONENT WAS REVISED BECAUSE THE SURGEON WANTED TO USE THE KINEMATIC ALIGNMENT FEMUR ON THIS PATIENT. IT GAVE BETTER LATERAL COVERAGE AND THE PATELLA TRACKED BETTER. SCAR TISSUE WAS PRESENT BUT NOTHING EXCESSIVE.

  Patient problems: Loss of Range of Motion

  MAUDE report 12923765 ↗
• InjuryJun 30, 2021Unstable

  REVISION SURGERY PERFORMED 3 YEARS AFTER THE PRIMARY DUE TO INSTABILITY IN MIDDLE-FLEXION, LATERAL AND MEDIAL COMPARTMENTS. STABILITY IN EXTENSION AND FLEXION. PATIENT WITH UNCOMFORTABLE FEELING IMMEDIATELY AFTER THE PRIMARY SURGERY. THE SURGEON REVISED ALL COMPONENTS BESIDES PATELLA RESURFACING.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 12091834 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem

  DURING THE PRIMARY BILATERAL KNEE SURGERY, THE SURGEON USED A + 3 EFFICIENCY BLOCK ON THE RIGHT KNEE AND INFORMED THE NURSE THAT HE WOULD NEED A 3+ FEMUR. THE NURSE INFORMED THE SALES REPRESENTATIVE, AND THE SALES REPRESENTATIVE INADVERTENTLY PROVIDED A SIZE 3 FEMUR, WHICH THE SURGEON IMPLANTED. THE IMPLANTATION OF THE SIZE 3 FEMUR CAUSED THE PATIENTS KNEE TO BE ELEVATED. THERE WAS NO DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 11884868 ↗
• InjuryNov 24, 2020Positioning Problem

  REVISION SURGERY FOR TOO MUCH KNEE FEMUR VALGUS POSITION 3 MONTHS AFTER PRIMARY SURGERY. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 10895800 ↗
• InjuryOct 29, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 5 MONTHS FROM THE PRIMARY SURGERY DUE TO SUSPECTED INFECTION BUT THE TESTS PERFORMED EXCLUDED INFECTION. ALL COMPONENTS WERE REVISED AND A SPACER WAS INSERTED( FOR 3 WEEKS). PERMANENT IMPLANTS WERE INSTALLED ON (B)(6) 2020. THE CAUSE OF THIS EVENT IS A FEELING OF GENERAL DISCOMFORT WITHOUT REAL PAIN OR INSTABILITY. DR (B)(6) DECIDED TO REVISE THE IMPLANTS BECAUSE THE PATIENT WAS NOT COMPLETELY SATISFIED DURING THE FIRST SURGERY.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 10755373 ↗
• InjuryOct 8, 2020Appropriate Device Problem Term/Code Not Available

  KNEE REVISION SURGERY 11 MONTHS AFTER PRIMARY. BEFORE THE REVISION SURGERY THE BACTERIOLOGICAL TESTS WERE POSITIVE TO ((B)(6)). THE SURGEON REVISED SUCCESSFULLY THE KNEE FEMUR AND TIBIAL IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 10647766 ↗
• InjurySep 30, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO AN ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REMOVED ALL IMPLANTS AND REVISED THEM WITH COMPETITOR PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 10604907 ↗
• InjuryJun 25, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 6 MONTHS AFTER THE PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE FEMORAL COMPONENT AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10194001 ↗
• InjuryOct 25, 2019Unstable

  REVISION SURGERY PERFORMED 1 YEAR AND 9 MONTHS AFTER THE PRIMARY DUE TO KNEE INSTABILITY CAUSED BY A PATELLA NECROSIS. THE REASON OF PATELLA NECROSIS IS UNKNOWN (NO INFECTION PRESENT). THE SURGEON REVISED THE INSERT AND FEMORAL AND TIBIAL COMPONENTS.

  Patient problems: Joint Disorder

  MAUDE report 9238376 ↗
• InjurySep 17, 2019Fracture

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A SUPRACONDYLAR FRACTURE 1 YEAR AFTER PRIMARY. THE CAUSE OF THE PERIPROSTHETIC IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 9075827 ↗
• InjuryMay 24, 2019Loss of or Failure to Bond; Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF LATERAL KNEE PAIN AFTER ABOUT 3 YEARS FROM THE PRIMARY SURGERY AND THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON PERFORMED A LATERAL FACETECTOMY. DURING THE PROCEDURE, THE SURGEON OBSERVED THAT THE CEMENT WAS NO LONGER ADHERED TO THE FEMORAL COMPONENT AND TIBIAL TRAY AND THE COMPONENTS WERE LOOSE. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND POLY WITH A COMPETITOR'S PRODUCT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8640301 ↗
• InjuryApr 17, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED, 2 YEARS AND 10 MONTHS AGO, DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 8522870 ↗
• InjuryFeb 8, 2019Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED, 4 YEARS AND 8 MONTHS AFTER PRIMARY SURGERY, DUE TO LOOSENING OF THE FEMORAL COMPONENT.

  Patient problems: Joint Disorder

  MAUDE report 8319903 ↗
• InjuryDec 28, 2017Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY WAS NECESSARY DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7150714 ↗