GMK Sphere Total Knee System 02.12.0310FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 07630030826337), received between Oct 4, 2017 and May 26, 2026 — classified as 57 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (12 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 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PAIN DUE TO HYPER EXTENSION AND THE CAUSE IS UNKNOWN. AT ABOUT 6 YEARS AND 6 MONTHS POST PRIMARY THE SURGEON REVISED THE PATIENT`S NATURAL PATELLA AND REVISED THE FLEX S3L - 10MM INSERT TO A FLEX 3L - 14MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 25275469 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY AND A "CLICKING" NOISE IN KNEE AND THE CAUSE IS UNKNOWN. THERE WAS NO REPORTS OF TRAUMA. THE SURGEON REVISED THE INSERT (FROM 10MM TO 14MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 25185351 ↗
• MalfunctionJul 2, 2025Positioning Failure; Positioning Failure

  IT WAS NOT POSSIBLE TO COUPLE THE PE INSERT WITH THE TINBN COATED TIBIAL TRAY. BACK-UP INSERT USED, BUT THE SAME PROBLEM OCCURRED. EVENTUALLY, THE SURGEON WAS ABLE TO SEAT THE LINER. DELAY 20-30 MIN (90 MINUTES TOTAL SURGERY)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22380966 ↗
• InjuryMay 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  BILATERAL TKA PERFORMED ON (B)(6) 2017. IN (B)(6) 2021, THE PATIENT HAD PAIN IN THE LEFT KNEE AND X-RAYS SHOWED THAT THE INLAY LOCKING SCREW HAD LOOSENED AND WAS FREE IN THE ANTERIOR PART OF THE JOINT. THE SCREW WAS THEN REMOVED ARTHROSCOPICALLY ON (B)(6) 2021. DURING THE SURGERY, SIGNS OF METALLOSIS WERE SEEN IN THE SOFT TISSUES, AND THE FEMORAL COMPONENT AND PE INLAY HAD SIGNS OF DAMAGE. AFTER THE SURGERY, THE PATIENT HAD PERSISTENT PAIN IN THE LEFT KNEE AND RADIOGRAPHIC CONTROLS SHOWED THE PRESENCE OF SMALL INTRA-ARTICULAR THIRD BODIES, PROBABLY METAL DEBRIS FROM THE SCREW OR FRAGMENTS OF SURGICAL INSTRUMENTS. NO OTHER INFORMATION AVAILABLE. TORQUE LIMITER WAS NOT AVAILABLE DURING THE PRIMARY SURGERY.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 22094478 ↗
• InjuryJan 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 YEARS 6 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21158679 ↗
• InjuryOct 23, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 YEAR AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 20512681 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 MONTHS AFTER THE PRIMARY, REVISION SURGERY DUE TO ARTHROFIBROSIS. CONSTANTLY REDUCED RANGE OF MOTION. INLAY CHANGE AND PATELLAR BONE RESURFACING PERFORMED AS WELL AS SOFT TISSUE ADAPTATION.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 20277216 ↗
• InjuryJan 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 YEAR 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE 10MM INSERT WITH A 14MM INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18502391 ↗
• InjuryDec 6, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18272869 ↗
• InjuryJul 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17395197 ↗
• InjuryJul 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2023. 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 THE LINER. 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 REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17296861 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (10MM) WITH A THICKER ONE (14MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17266659 ↗
• InjuryJun 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17123886 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN. THE SURGEON OBSERVED THAT THE PATIENTS MCL (MEDIAL COLLATERAL LIGAMENT) WAS NOT FUNCTIONING PROPERLY AND WAS UNSTABLE AND THE CAUSE IS UNKNOWN. AT ABOUT 3 WEEKS POST PRIMARY THE SURGEON REVISED THE TIBIA, FEMUR, AND INSERT WITH HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16495667 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (FROM 10MM TO 17MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16467469 ↗
• InjuryJan 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 5 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16232617 ↗
• InjuryDec 16, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AND 15 DAYS 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 THE TIBIAL INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 15995219 ↗
• InjuryDec 15, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 WEEK POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 15987442 ↗
• InjuryDec 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (10MM) TO A THICKER ONE (12MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15959145 ↗
• InjuryDec 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY PERFORMED FOR KNEE INFECTION, THE PATHOGEN AND THE PRIMARY SURGERY DATE ARE UNKNOWN. THE KNEE LINER WAS REVISED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 15893670 ↗
• InjuryNov 28, 2022No Apparent Adverse Event; No Apparent Adverse Event

  AT ABOUT 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING STIFFNESS IN THE KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 15868961 ↗
• InjuryNov 4, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 3 MONTHS FROM SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15734460 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED DUE TO PAIN AND LAXITY ABOUT 2 YEARS AFTER THE PRIMARY SURGERY. PATELLA BONE RESURFACED AND INLAY CHANGED WITH A THICKER ONE (FROM 10 TO 12 MM).

  Patient problems: Loss of Range of Motion

  MAUDE report 15666143 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY, THE PATIENT REPORTED PATIENT DISSATISFACTION AND PAIN MOSTLY ANTERIOR. PATELLOFEMORAL PRESSURE LEAD TO THINNING ESPECIALLY OF LATERAL PATELLAR BONE. RESURFACING OF PATELLAR BONE AND INLAY EXCHANGE (10MM TO 12 MM) HAVE BEEN PERFORMED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15665649 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT ABOUT 1 YEAR AND 1 MONTH POST PRIMARY SURGERY THE SURGEON REVISED THE INSERT AND IMPLANTED A THICKER ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15326895 ↗