GMK Sphere Total Knee System 02.12.0005LRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07630030825859), received between Sep 6, 2017 and Mar 10, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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.

• InjuryMar 10, 2026Malposition of Device

  REVISION SURGERY WAS PERFORMED 6 MONTHS AFTER THE PRIMARY PROCEDURE DUE TO MALPOSITIONING OF THE FEMORAL COMPONENT. THE SURGEON OBSERVED THAT THE FEMORAL COMPONENT HAD BEEN IMPLANTED WITH MALROTATION DURING THE PRIMARY SURGERY. DURING THE REVISION PROCEDURE, THE NATIVE PATELLA WAS REVISED, THE 12 MM INSERT WAS REPLACED WITH A 14 MM SEMI-CONSTRAINED INSERT, AND THE GMK-SPHERE SIZE 5 FEMORAL COMPONENT WAS REPLACED WITH A GMK-REVISION SIZE 5 FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 24558209 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 6 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS. THE SURGEON REVISED THE INSERT AND FEMUR WITH A SC 17MM LINER AND A REVISION FEMUR BUT NO ISSUES WERE REPORTED WITH THE IMPLANTS. SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 21570572 ↗
• InjuryFeb 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ON (B)(6) 2016, THE PATIENT HAD KNEE PRIMARY SURGERY. ON (B)(6) 2023, THE PATIENT HAD AN ADDITIONAL SURGERY PERFORMED DUE TO INLAY LOCKING SCREW UNSCREWING (LEFT KNEE). THE INLAY LOCKING SCREW WAS REMOVED ARTHROSCOPICALLY. ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION SURGERY OF THE LEFT KNEE DUE TO INFECTION. ONLY THE LINER WAS REVISED. ON (B)(6) 2023, THE PATIENT UNDERWENT A TOTAL KNEE REVISION SURGERY DUE TO INFECTION. THE EXACT DATE OF THE SURGERY, THE HOSPITAL, AND THE SURGEON ARE UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 21458564 ↗
• InjuryJan 8, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LOOSE COMPONENTS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21100349 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AT ABOUT 3 YEARS AND 1 MONTH POST PRIMARY DUE TO DISSATISFACTION POSTOPERATIVE, CHRONIC KNEE PAIN, NO DETECTED INFECTION. ACCORDING TO SURGEON DUE TO INSTABILITY OF THE KNEE. REMOVAL OF COMPONENTS AND CHANGE TO GMK HINGE.

  Patient problems: Joint Laxity

  MAUDE report 20396521 ↗
• InjuryAug 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 6 YEARS 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN, DUE TO A LOOSE FEMORAL COMPONENT. THE SURGEON REVISED THE FEMORAL COMPONENT, POLY AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 20020770 ↗
• InjuryNov 2, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO LAXITY, AT ABOUT 3 YEARS 4 MONTHS FROM THE PRIMARY. THE PATIENT CAME IN REPORTING PAIN AND DISCOMFORT. DURING REVISION, AFTER LITTLE ITTING WITH A BONE TAMP, FEMORAL COMPONENT CEMENTED WAS EASY TO TAKE OUT. NO CEMENT ON BACKSURFACE. THE SURGEON REVISED SUCCESSFULLY THE FEMUR AND INSERT (10 TO 14 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18054068 ↗
• InjurySep 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE POLY. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN AFTER FALLING DIRECTLY ON THE KNEE, WHICH CAUSED THE INSERT TO DISENGAGE FROM THE BASEPLATE. THE SURGEON REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED SUCCESSFULLY NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 17734995 ↗
• InjurySep 6, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 2 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMORAL COMPONENT AND TIBIAL TRAY. THE SURGEON REVISED THE FEMORAL COMPONENT, INSERT, TIBIAL TRAY AND PATELLA COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17689781 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 1 DAY AFTER THE PRIMARY SURGERY, THE PATIENT REPORTED PAIN AND LAXITY. THE PCL (POSTERIOR CRUCIATE LIGAMENT) AND MCL (MEDIAL COLLATERAL LIGAMENT) WERE FOUND TO BE COMPROMISED, THEREFORE THE SURGEON DECIDED TO REVISE THE FEMORAL COMPONENT AND THE LINER TO SWITCH TO A CONSTRAINED PROSTHESIS.

  Patient problems: Joint Laxity

  MAUDE report 15484042 ↗
• InjuryApr 25, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO LOOSE IMPLANTS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS WITH REVISION COMPONENTS 2 YEARS AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO CEMENT ADHERED TO THE IMPLANTS. THE CAUSE OF THIS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 14191915 ↗
• InjuryNov 7, 2021Appropriate Device Problem Term/Code Not Available

  LEFT KNEE REVISION SURGERY DUE TO INFECTION WAS PERFORMED 1 YEAR AFTER THE PRIMARY SURGERY. HINGE SYSTEM IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 12758076 ↗
• InjuryApr 15, 2021Loose or Intermittent Connection

  REVISION SURGERY PERFORMED DUE TO FEMUR AND TIBIAL TRAY LOOSENING 3 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11670242 ↗
• InjuryDec 27, 2019Loosening of Implant Not Related to Bone-Ingrowth

  ABOUT 1 YEAR AND 2 MONTHS AFTER PRIMARY THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON OBSERVED THAT ALL THE COMPONENTS WERE LOOSE AND THAT THE CEMENT DID NOT HOLD DURING THE PRIMARY SURGERY. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, POLY, AND PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9523296 ↗
• InjuryJun 12, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 2 YEARS AND 10 MONTHS AFTER PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND EXPLANTED THE FEMORAL COMPONENT, TIBIAL TRAY, POLY AND PATELLA. THE SURGEON IMPLANTED A TEMPORARY SPACER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8691457 ↗
• InjuryApr 20, 2018Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED BECAUSE THE FEMORAL COMPONENT WAS TOO LARGE LIMITING THE ABILITY TO FLEX, 1 YEAR AND 2 MONTHS AFTER PRIMARY. THE FEMUR WAS EXPLANTED AND A SMALLER SIZE SPHERE WAS IMPLANTED ON ITS PLACE.

  Patient problems: Joint Disorder

  MAUDE report 7446081 ↗
• InjurySep 6, 2017Insufficient Device Problem Information

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS CONFIRMED AS (B)(6). THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 6844647 ↗