GMK Sphere Total Knee System 02.12.0512FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 07630030826788), received between Jul 17, 2017 and Mar 16, 2026 — classified as 38 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Device Appears to Trigger Rejection

  REVISION SURGERY AFTER 3 YEAR AND 4 MONTHS DUE TO INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TRAY, FEMUR, AND INSERT TO GMK-REVISION, AND REVISED THE PATIENT`S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24603546 ↗
• InjuryJun 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN WITH SIGNS OF INFECTION, AND THE PATHOGEN IS UNKNOWN. ABOUT 2 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22149348 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS AND 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO DEVELOPING ANKYLOSING SPONDYLITIS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE POLY (12MM) WITH A THICKER ONE (17MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT IS NOT KNOWN THE REASON OF THE POLY REVISION.

  Patient problems: Loss of Range of Motion

  MAUDE report 20817093 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (12MM TO 14MM) AND THE SURGERY WAS COMPLETELY SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 20530681 ↗
• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AND 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (12 MM) WITH A THICKER ONE (14 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19517346 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (12MM) WITH A THICKER ONE (13MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19097062 ↗
• InjuryFeb 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 11 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 18701122 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ABOUT 6 MONTHS AND A HALF AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED BY THE SURGEON THAT THE PATIENT'S KNEE WAS UNSTABLE. AFTER FURTHER DISCUSSION, IT WAS CONCLUDED THAT A CUSTOM SIZE POLY IMPLANT IS NEEDED FOR THE PATIENT (GMK-SPHERE TIBIAL INSERT WITH A 14MM MID-COMPARTMENT THICKNESS AND 11MM LATERAL THICKNESS). REVISION WILL BE PERFORMED.

  Patient problems: Joint Laxity

  MAUDE report 18657577 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AT ABOUT 1 YEAR AND 8 MONTHS POST PRIMARY FOR KNEE 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 18256289 ↗
• InjurySep 14, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (12 TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17744510 ↗
• InjuryJul 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY 10 DAYS POST PRIMARY DUE TO INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATHOGEN IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 17413797 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AND 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY WAS UNKNOWN. THE SURGEON REVISED THE LINER (FROM 12 TO 14 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17396948 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 5 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER WITH A THICKER ONE (FROM 12 TO 17 MM) DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 15402218 ↗
• InjuryJul 22, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 5 MONTHS 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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15082822 ↗
• InjuryJan 24, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. AT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE 12MM POLY TO A 17MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13333121 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem

  AT 7 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PATELLA PAIN AND THE CAUSE IS UNKNOWN, BUT IT WASN`T RELATED TO THE IMPLANT. THE SURGEON PERFORMED A LATERAL RELEASE AND REVISED THE POLY AS A STANDARD PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 12916762 ↗
• InjuryNov 15, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12810643 ↗
• InjuryNov 3, 2021Appropriate Device Problem Term/Code Not Available

  AT 6 MONTHS AND 13 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 12743104 ↗
• InjuryOct 18, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING KNEE PAIN AND INSTABILITY AND THE CAUSE OF THE PAIN INSTABILITY IS UNKNOWN. 1 YEAR AND 7 MONTHS AFTER PRIMARY THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT - FLEX S5R - 12MM WITH A GMK-SPHERE TIBIAL INSERT - FLEX S5R - 17MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12645620 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON DOWNSIZED THE POLY FROM A 13MM TO A 12MM. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, 3 YEARS 5 MONTHS AFTER THE PREVIOUS SURGERY 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 11770231 ↗
• InjuryJan 26, 2021Adverse 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 POLY, 12 DAYS AFTER THE PRIMARY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11229072 ↗
• InjuryDec 13, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, THREE MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10998953 ↗
• InjuryOct 28, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 3 MONTHS AFTER PRIMARY SURGERY, REPORTING INSTABILITY DUE TO LAXITY IN THE KNEE. THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT - FLEX S5R - 12 MM WITH A SPHERE INSERT FLEX RIGHT 13MM S5. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 10746080 ↗
• InjuryJun 25, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN QUADRICEPS TENDON. 1 YEAR AND 1 MONTH AFTER PRIMARY THE SURGEON REPAIRED THE TENDON AND REVISED THE 12MM POLY WITH A 14MM POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10193884 ↗
• InjuryApr 15, 2020Loosening of Implant Not Related to Bone-Ingrowth

  ABOUT TWO YEARS AFTER PRIMARY SURGERY THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY IN THE KNEE. THE SURGEON REVISED THE MEDACTA SPHERE INSERT FLEX RIGHT 12MM SIZE 5 WITH A MEDACTA SPHERE INSERT FLEX RIGHT 17MM SIZE 5. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9961387 ↗