GMK Sphere Total Knee System 02.12.0311FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07630030862588), received between Feb 8, 2018 and May 5, 2026 — classified as 29 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 YEARS AND 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING ANTERIOR KNEE PAIN AND INSTABILITY. THE SURGEON REVISED THE PATIENT`S NATURAL PATELLA AND THE INSERT FOR STABILITY (FROM 11MM TO 12MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25077216 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 YEARS 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE POLY (11 TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21585876 ↗
• InjuryOct 15, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 YEAR AND 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: Medical device site infection

  MAUDE report 20448873 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (11 TO 14 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19593162 ↗
• InjuryJun 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 6 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER (FROM 11 TO 14 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19518512 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 YEARS AND 9 MONTHS AFTER 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: Medical device site infection

  MAUDE report 18648759 ↗
• InjuryJan 31, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HOLD FOR RW 1.31 AT ABOUT 2 MONTHS 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18613589 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR KNEE INSTABILITY, THE CAUSE IS UNKNOWN. AT ABOUT 2 YEARS FROM THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT TO A THICKER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18235861 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 YEARS 10 MONTHS 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 18020153 ↗
• InjuryJun 6, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND INSTABILITY AND THE PATHOGEN IS UNKNOWN. ABOUT 2 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17070260 ↗
• InjuryMar 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 MONTHS AFTER THE PRIMARY, REVISON SURGERY PERFORMED DUE TO INFECTION. THE INSERT WAS REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16655291 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE SURGEON REVISED THE LINER WITH A THICKER ONE (FROM 11 TO 14 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15444793 ↗
• InjuryAug 17, 2022Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (11 MM TO 17 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15240483 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AD 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE LINER (11MM) WITH A THICKER ONE (14MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15217723 ↗
• InjuryMar 8, 2022Appropriate Device Problem Term/Code Not Available

  AT 4 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (11 TO 14 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13693396 ↗
• InjuryOct 18, 2021Appropriate Device Problem Term/Code Not Available

  AT 20 DAYS 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: Unspecified Infection

  MAUDE report 12647416 ↗
• InjuryJun 4, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE 11MM INSERT WITH A 14MM ONE TO GIVE THE PATIENT MORE STABILITY 1 YEAR AND 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11938575 ↗
• InjuryMay 31, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED AN I&D AND REVISED THE SPHERE INSERT FLEX RIGHT 11MM S3 WITH A SPHERE INSERT FLEX RIGHT 11MM S3. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED AN I&D AND PUT A TEMPORARY SPACER (REVISED ALL THE COMPONENTS). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11907495 ↗
• InjuryMay 17, 2021Unstable

  5 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A HYPEREXTENDED KNEE. THE CAUSE OF THE HYPEREXTENDED KNEE IS UNKNOWN. THE SURGEON REVISED THE SPHERE INSERT FLEX RIGHT 11MM S3 WITH A GMK-SPHERE TIBIAL INSERT - FLEX S3R - 17MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11830863 ↗
• InjuryJul 28, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE POLY 11 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON ALSO ADDED ANTIBIOTIC CEMENT. THE SAME PATIENT WAS SCHEDULED TO COME IN ON (B)(6) 2020, AND THE SURGEON CHECKED HIM TO SEE IF THERE WAS AN INFECTION (THERE WAS NOT) AND SAW THAT THE CEMENT DAMAGED THE POLY. THE SURGEON DID A POLY-SWAP AGAIN.

  Patient problems: Unspecified Infection

  MAUDE report 10331242 ↗
• InjuryJun 16, 2020Appropriate Device Problem Term/Code Not Available

  HE PATIENT CAME IN REPORTING PAIN 4 MONTHS AFTER THE PRIMARY SURGERY AND THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND INSERT AND CONVERTED THE PATIENT TO A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10156627 ↗
• InjuryMay 19, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 1.5 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED AN I&D AND REVISED THE SPHERE INSERT FLEX RIGHT 11MM S3 WITH A SPHERE INSERT FLEX RIGHT 11MM S3. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10069394 ↗
• InjuryDec 4, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 15 DAYS AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9408356 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE MEDACTA SPHERE INSERT FLEX RIGHT 11MM S3 WITH A MEDACTA SPHERE INSERT FLEX RIGHT 11MM S3, 3 WEEKS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9334635 ↗
• InjurySep 26, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 3 YEARS AND 3 MONTHS AFTER PRIMARY THE PATIENT CAME IN COMPLAINING OF INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON SWAPPED THE INSERT TO A 2MM THICKER ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9123019 ↗