GMK Sphere Total Knee System 02.12.0002LRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630030825798), received between Aug 3, 2017 and Dec 2, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Implant subsidence; Implant subsidence

  AT ABOUT 3 YEARS 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED FEMORAL COMPONENT AND THE CAUSE IS UNKNOWN. THE SURGEON NOTED THAT THE PATIENT'S OVERWEIGHT CONDITION MAY HAVE CONTRIBUTED, ALTHOUGH SOFT BONE QUALITY AND IMPLANT SIZE SELECTION WERE EXCLUDED AS POTENTIAL FACTORS. THE SURGEON REVISED THE GMK-SPHERE FEMUR, INSERT, AND TIBIAL TRAY WITH GMK-REVISION FEMUR, INSERT, AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 23694046 ↗
• InjuryDec 29, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING KNEE PAIN AFTER 5 MONTHS FROM THE PRIMARY SURGERY. POST-OP X-RAYS INDICATED THAT FEMORAL COMPONENT AND TIBIAL TRAY WERE LOOSE. THE REASON FOR THE LOOSE COMPONENTS IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11087672 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR KNEE INFECTION 2 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11063590 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR KNEE INFECTION 2 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11011326 ↗
• InjuryJul 3, 2020Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2015. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. ON (B)(6) 2017, THE SURGEON REVISED THE 14MM POLY WITH A 20MM POLY. PRESENTLY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO LAXITY. THE SURGEON PLANS TO REVISE ALL IMPLANTS AND A REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2020.

  Patient problems: Joint Disorder

  MAUDE report 10229321 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 WE WERE INFORMED THAT THE PATIENT HAD COME IN DUE TO SIGNS OF INFECTION AND THE SURGEON HAD REMOVED ALL MEDACTA HARDWARE AT AN UNKNOWN DATE. THE PATHOGEN WAS CONFIRMED AS (B)(6). ON (B)(6) 2018 THE SURGEON REVISED THE SPACER AND IMPLANTED PERMANENT HARDWARE (5 MONTHS AFTER THE PRIMARY).

  Patient problems: Unspecified Infection

  MAUDE report 8069024 ↗
• InjuryFeb 16, 2018Appropriate Device Problem Term/Code Not Available

  THIS SURGEON DID A BILATERAL SURGERY ON (B)(6) 2017. POST-OPERATIVELY HE NOTICED THAT THE PATIENT'S FEMORAL COMPONENT APPEARED TO BE CALCULATED BY THE COMPUTER TO BE TOO LARGE. IN ADDITION, IT ALSO SEEMED THAT THE MYKNEE BLOCKS PLACED THE FEMUR IN A GREATER VALGUS POSITION THAN WHEN HE USES INSTRUMENTS. THE SURGEON DECIDED TO OBSERVE THIS PATIENT OVER THE NEXT FEW MONTHS. THE PATIENT CAME IN COMPLAINING ABOUT THEIR KNEE NOT FEELING STRAIGHT. THE SURGEON DOWNSIZED THE FEMUR FROM SIZE 2 TO 1 (REF 02.07.2401L REV. FEMUR P.S. CEMENTED LEFT S1); THE NEW LINER IMPLANTED WAS REF (B)(6) INSERT SEMICONSTRAINED 14MM S2 (SO 3MM THICKER). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 7276210 ↗
• InjuryNov 23, 2017Material Deformation

  THE TIBIAL AND FEMUR BONE DEFORMED TILL THE FINAL BREAKAGE. THE REASON OF DEFORMATION IS UNKNOWN. REVISION PERFORMED. ALL THE DEVICES WERE REMOVED AND A GMK-REVISION IMPLANTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 7057081 ↗
• MalfunctionAug 3, 2017Loose or Intermittent Connection; Difficult To Position

  DURING A PRIMARY LEFT KNEE CASE. AFTER ALL CUTS WERE MADE, THE SURGEON TRIALED WITH A FEMORAL TRIAL SIZE 2L, WHEN HE MOVED FROM EXTENSION INTO FLEXION THE FEMORAL TRIAL BECAME UNSEATED FROM THE FEMUR. THE SURGEON WAS UNABLE TO GET THE TRAIL TO SEAT BACK ONTO THE FEMUR. THERE WAS A DELAY OF APPROXIMATELY 7 MINUTES. THE SURGEON OPENED THE IMPLANT TO TRAIL WITH THE IMPLANT. THE IMPLANT WAS ALSO LOOSE. THE SURGEON CEMENTED THE IMPLANT INTO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6763298 ↗