GMK Sphere Total Knee System 02.12.0610FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07630030826931), received between Jun 27, 2017 and May 15, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS AND 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FLEX S6L - 10MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25185345 ↗
• InjuryAug 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 10 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; Unspecified Infection

  MAUDE report 20030259 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (10 MM TO 12 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18333560 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED DUE TO KNEE INSTABILITY. THE LINER WAS REVISED FROM A 10MM TO A 13MM. DURING THE REVISION, CIRCULAR INCISIONS WERE NOTED ON THE MEDIAL AND LATERAL COMPARTMENTS OF THE EXPLANTED LINER. ALSO, CEMENT PARTICLES WERE FOUND ON THE PATELLA.

  Patient problems: Joint Laxity

  MAUDE report 16960272 ↗
• InjuryOct 10, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN AND WAS IMPLANTED WITH PERMANENT HARDWARE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, 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 15571998 ↗
• InjurySep 19, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 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: Unspecified Infection

  MAUDE report 15444794 ↗
• InjuryJul 21, 2022Contamination

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

  Patient problems: Unspecified Infection

  MAUDE report 15073933 ↗
• InjuryApr 20, 2022Adverse 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 ALMOST 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14159945 ↗
• InjuryFeb 21, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANTED COMPONENTS: 02.12.E0610FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 6L -10MM 2012410. 02.07.0034RP PATELLA RESURFACING S2 2111891.

  Patient problems: Pain

  MAUDE report 13567342 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem

  1 MONTH 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 12546615 ↗
• InjuryMar 31, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 7 MONTHS AFTER THE 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 11593953 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem

  1 MONTH POST OPERATION, THE PATIENT RETURNED WITH SIGNS OF PERIPROSTHETIC JOINT INFECTION. DIAR (DEBRIDEMENT, ANTIBIOTICS AND IMPLANT RETENTION) HAS BEEN PERFORMED AND THE LINER HAS BEEN SUCCESSFULLY REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 10860232 ↗
• InjuryNov 17, 2020Material Rupture; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A RUPTURED ARTHROTOMY, 2 MONTHS AFTER PRIMARY SURGERY. THE CAUSE OF THE RUPTURED ARTHROTOMY IS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT - FLEX S6L - 10 MM WITH A GMK-SPHERE TIBIAL INSERT - FLEX S6L - 10 MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10852284 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 9749833 ↗
• InjuryJul 23, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT TWO MONTHS AFTER PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD ALREADY A PREVIOUS REVISION FOR INFECTION 1 MONTH AFTER PRIMARY.

  Patient problems: Unspecified Infection

  MAUDE report 8814969 ↗
• InjuryJul 4, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 2 MONTH AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE BECAUSE PAINFUL AND NOT ABLE TO ACHIEVE FULL EXTENSION. THE SURGEON REVISED SUCCESSFULLY THE 10MM INSERT WITH A 12MM INSERT AND THE FEMORAL COMPONENT.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 8762588 ↗
• InjuryMay 28, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 21 DAYS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND LINER-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8645809 ↗
• InjuryMar 22, 2018Appropriate Device Problem Term/Code Not Available

  FIVE MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A KNEE INSTABILITY. THE LINER HAVE BEEN SWAPPED PASSING FROM A 10MM TO A 13MM ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7361001 ↗
• InjurySep 8, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 6851060 ↗
• InjuryJun 27, 2017Inadequacy of Device Shape and/or Size

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF THE PAIN IN UNKNOWN. THE SURGEON SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON STATED THAT NOTHING WAS VISIBLE ON THE X-RAYS, SOMEHOW THE KNEE STRETCHED OUT AND THE POLY IS TO BE UPSIZED FROM A 10 TO A 17 IN ORDER FOR THE KNEE TO BECOME STABLE AGAIN. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Pain

  MAUDE report 6669346 ↗