GMK Sphere Total Knee System 02.12.0023LRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07630030862373), received between Dec 13, 2017 and Aug 8, 2025 — classified as 17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  6 YEARS AFTER THE PRIMARY SURGERY, THE PATIENT REPORTED STIFFNESS WITH ONLY A 3° RANGE OF MOTION. THE SURGEON PERFORMED SOFT TISSUE RELEASES, DOWNSIZED THE FEMUR BY TWO SIZES, AND REVISED THE INSERT (WITH ONE OF THE SAME SIZE) AND PATELLA DUE TO TRACKING ISSUES. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO MEDACTA PRODUCT ISSUE IDENTIFIED.

  Patient problems: Loss of Range of Motion

  MAUDE report 22749124 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 11 MONTHS FROM PRIMARY THE PATIENT CAME IN REPORTING DISTAL FEMUR PAIN. AN X-RAY SHOWED THE CEMENT MANTEL WAS CRACKED ON THE FEMUR. THE SURGEON DECIDED TO REVISE THE FEMUR AND POLY. SURGERY WAS COMPLETED SUCCESSFULLY, FEMUR WAS DOWNSIZED FROM 3+ TO 3 AND POLY OF THE SAME THICKNESS (10MM) WAS USED. NO MOBILIZATION OF THE FEMUR WAS REPORTED WHILE THE TYPE OF CEMENT USED IS NOT KNOWN.

  Patient problems: Pain

  MAUDE report 21975646 ↗
• InjuryJul 16, 2024Migration; Migration

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING INSTABILITY. ON (B)(6) 2023, THE SURGEON REVISED THE 12MM INSERT WITH A 17MM INSERT. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN QUADRICEPS TENDON RESULTING FROM AN ACTION OF THE PATIENT. THE SURGEON REPAIRED THE TENDON AND REVISED THE 17MM INSERT WITH A 20MM INSERT BUT THE INSERT WOULD NOT FULLY SEAT ONTO THE TIBIAL TRAY. THE SURGEON USED ANOTHER 20MM INSERT WITH THE SAME LOT NUMBER AND IT SEATED WITH NO ISSUES. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024 THE PATIENT SUFFERED FROM POOR PATELLAR BONE TRACKING AND A FEMORAL COMPONENTS IN TOO MUCH VARUS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR AND INSERT (AS PER STANDARD PROCEDURE). THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 19749801 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 2 YEARS AND 4 MONTHS POST PRIMARY THE SURGEON REVISED THE INSERT AND FEMUR AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19040627 ↗
• InjuryDec 11, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND KNEE PAIN DUE TO A LOOSE PATELLA IMPLANT, FEMORAL COMPONENT AND TIBIAL TRAY. THE SURGEON REVISED THE PATELLA IMPLANT, FEMORAL COMPONENT, INSERT AND TIBIAL TRAY. THE INSERT WAS INCREASED FROM AN 11MM TO A 14MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18301128 ↗
• InjuryNov 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY FOR INFECTION AT ABOUT 3 YEARS, 1 MONTH AND A HALF POST PRIMARY, ALL COMPONENTS REVISED SUCCESSFULLY. THE PATHOGEN IS NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 18138173 ↗
• InjuryFeb 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 5 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16451655 ↗
• InjuryOct 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 5 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY ALL THE COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 15672129 ↗
• InjuryDec 20, 2021Unstable

  AT 8 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING INSTABILITY AND HYPEREXTENSION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT. THE SURGEON USED A THICKER LINER TO PROVIDE GREATER VARUS/VALGUS STABILITY AND REVISED THE FEMORAL COMPONENT TO GIVE THE PATIENT A POST TO REDUCE HYPEREXTENSION.

  Patient problems: Joint Laxity

  MAUDE report 13042814 ↗
• InjuryOct 7, 2021Detachment of Device or Device Component

  2 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN. THE SURGEON OBSERVED THAT THE TIBIA TENDON HAD COME OFF AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR, TIBIA, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 12589967 ↗
• InjuryJul 12, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR AND THE CAUSE OF THE FRACTURED FEMUR IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT 17 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 12149878 ↗
• InjuryNov 15, 2018Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN COMPLAINING OF LOOSENING OF THE KNEE 2 YEARS AND 8 MONTHS AFTER PRIMARY SURGERY. WHEN THE PATIENT WAS UNDER, THE SURGEON DETERMINED THE FEMUR AND PATELLA WERE LOOSE. THE SURGEON FOUND THAT THE CEMENT DID NOT ADHERE TO THE FEMUR. THE SURGEON REVISED THE FEMUR, INSERT AND PATELLA.

  Patient problems: Joint Dislocation

  MAUDE report 8073324 ↗
• InjurySep 14, 2018Appropriate Device Problem Term/Code Not Available

  ABOUT 2 YEARS AFTER PRIMARY REVISION SURGERY FOR GENERIC PAIN. THE REASON OF PAIN IS UNKNOWN. FEMUR AND LINER SWAP. PATELLA RESURFACING PERFORMED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 7876590 ↗
• InjurySep 12, 2018Microbial Contamination of Device

  ABOUT 1 YEAR AND 3 MONTHS AFTER PRIMARY THE PATIENT CALLED THE AGENT COMPLAINING ABOUT A REVISION SHE HAD TO UNDERGO. THE PATIENT EXPLAINED THAT SHE WAS REVISED DUE TO POTENTIAL INFECTION. THE PATIENT WAS REVISED BY A NON MEDACTA SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 7868586 ↗
• InjuryJan 12, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON REMOVED ALL MEDACTA IMPLANTS ON (B)(6) 2017. THE SALES AGENT BECAME AWARE OF THE REVISION ON (B)(6) 2017. THE PATIENT HAD THE SPACER REMOVED ON (B)(6) 2018 AND MEDACTA COMPONENTS WERE IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7185747 ↗
• InjuryDec 29, 2017Loose or Intermittent Connection

  REVISION SURGERY PERFORMED DUE TO LOOSENING (FEMORAL AND TIBIAL COMPONENT) 1 YEAR AND 8 MONTHS AFTER PRIMARY. THE SURGEON REVISED ALL MEDACTA COMPONENTS AND RE-IMPLANTED ANOTHER COMPANY'S PRODUCT .

  Patient problems: Joint Disorder

  MAUDE report 7153839 ↗
• InjuryDec 13, 2017Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE PATIENT PRESENTED WITH A VALGUS KNEE. THE SURGEON REVISED ALL MEDACTA HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7112597 ↗