GMK Sphere Total Knee System 02.12.0411FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07630030862625), received between Oct 31, 2017 and Jun 17, 2026 — classified as 29 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (6 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.

• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 3 YEARS AND 8 MONTHS DUE TO INSTABILITY. THE SURGEON REVISED THE 11MM S4 INSERT TO A 14MM FLEX 4R INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 25528758 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 YEARS AND 3 MONTHS FROM PRIMARY THE PATIENT REPORTED INSTABILITY OF THE KNEE. THE SURGEON REVISED THE 11MM INSERT TO 14MM INSERT. SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24208582 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING LAXITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE LINER TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23850111 ↗
• InjuryOct 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 4 YEARS AND 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING AN INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Medical device site infection

  MAUDE report 23349011 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 YEARS AND 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE NATURAL PATELLA AND UPSIZED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21975204 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE 11MM POLY WITH A 17MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21122117 ↗
• InjuryJun 12, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ON THE (B)(6) 2020 THE PATIENT UNDERWENT PRIMARY SURGERY. SUBSEQUENTLY, ON THE (B)(6) 2023, THE PATIENT HAS BEEN REVISED BECAUSE OF INFECTION (EMDR 2023-00929). THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE LINER. PRESENTLY, ON THE (B)(6) 2024, THE PATIENT CAME IN REPORTING INFECTION. A WASHOUT WAS PERFORMED AND THE LINER WAS SUCCESSFULLY REVISED.

  Patient problems: Medical device site infection

  MAUDE report 19517490 ↗
• InjuryMay 24, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 7 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: Unspecified Infection

  MAUDE report 19390098 ↗
• InjuryDec 6, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ABOUT 3 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, REVISION SURGERY WAS PERFORMED DUE TO INFECTION. WASH-OUT PERFORMED AND LINER REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 18272888 ↗
• InjuryNov 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH 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 18158252 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR KNEE INSTABILITY. AT ABOUT 5 YEARS AND 6 MONTHS POST PRIMARY THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17133669 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR KNEE INSTABILITY AT 1 YEAR FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT IMPLANTING A 3MM TICKER LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17097349 ↗
• InjuryJan 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PATELLA PAIN AND THE CAUSE WAS UNKNOWN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, 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 16162279 ↗
• InjuryDec 22, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 YEAR AND 10 MONTHS AFTER THE PRIMARY SURGERY, REVISION WAS PERFORMED DUE TO KNEE SNAPPING DURING WALKING. NO PAIN WAS REPORTED BY THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY REVISING THE TIBIAL INSERT (14MM) WITH AN INSERT OF THE SAME THICKNESS (14MM), RESTORING THE STABILITY OF THE KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16032554 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING STIFFNESS AND THE CAUSE IS UNKNOWN. AT ABOUT 3 MONTHS FROM PRIMARY THE SURGEON PERFORMED A SYNOVECTOMY AND DOWNSIZED FROM AN 11 TO A 10MM POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996266 ↗
• InjuryJul 15, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  AT 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE 11MM POLY WITH A 17MM POLY AND REVISED THE FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15025735 ↗
• InjuryApr 21, 2021Appropriate Device Problem Term/Code Not Available

  ONE WEEK 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 THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11700208 ↗
• InjuryDec 13, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 3 YEARS AND 7 MONTHS AFTER PRIMARY SURGERY, 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 10998936 ↗
• InjuryAug 26, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN, 23 DAYS AFTER THE PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10452931 ↗
• InjuryMar 24, 2020Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY 4 YEARS AND 44 DAYS AFTER THE PRIMARY SURGERY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE MEDACTA SPHERE INSERT FLEX RIGHT 11MM S4 WITH A MEDACTA SPHERE INSERT FLEX RIGHT 14MM S4. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9872419 ↗
• InjuryMar 4, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION 3 MONTHS AFTER THE PRIMARY, 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 9786033 ↗
• InjuryNov 25, 2019Microbial Contamination of Device; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 2 MONTHS 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 9368476 ↗
• InjuryJul 25, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  ABOUT 2 YEARS AND A HALF AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR LINER FIXATION SCREW UNSCREWING. THE SURGEON REMOVED THE SCREW AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8825504 ↗
• InjuryJul 5, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 4 MONTHS FROM THE PRIMARY DUE TO AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED AN I&D AND REVISED THE INLAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8764305 ↗
• InjuryMay 28, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 2 YEARS AND A HALF AFTER PRIMARY SURGERY, COMPLAINING OF ANTERIOR KNEE PAIN AND THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON RESURFACED THE PATELLA AND REVISED THE 11MM POLY WITH A 13MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8645814 ↗