GMK Sphere Total Knee System 02.12.0513FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030862656), received between Mar 16, 2018 and Mar 31, 2026 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Device Appears to Trigger Rejection

  AT7 YEARS 5 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 13MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24738809 ↗
• InjuryApr 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. 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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN AFTER FALLING DIRECTLY ON THE KNEE, WHICH CAUSED THE POLY TO DISENGAGE FROM THE BASEPLATE. THE SURGEON REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. DURING THE PRIMARY SURGERY, THE REP DIDN'T HEAR A CLICK SOUND AT LINER COUPLING WITH THE TIBIAL BASE AND WASN'T SURE IF THE DOCTOR HEARD A CLICK SOUND. THE SURGEON SAID IT LOOKED LIKE THE LINER WAS IN, BUT ITS POSSIBLE IT WASN'T IN POSTERIORLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16687667 ↗
• InjuryMar 21, 2023Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 16582833 ↗
• InjuryDec 14, 2022Device 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 PAIN DUE TO ASEPTIC LOOSENING AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS EXCEPT THE PATELLA 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 PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 15976101 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem

  2 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE OF BOTH THE PAIN AND INSTABILITY IS UNKNOWN. THE SURGEON DECIDED TO GIVE THE PATIENT A FULL REVISION AND REVISE THE FEMUR, TIBIA, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12353121 ↗
• InjuryMay 11, 2021Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2018. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED GMK-SPHERE TIBIAL INSERT - FLEX S5L - 12 MM WITH A SPHERE INSERT FLEX LEFT 13MM S5 TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, 1 MONTH AFTER REVISION SURGERY FOR INSTABILITY, 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 11804171 ↗
• InjuryDec 7, 2020Unstable

  THE PATIENT CAME IN AFTER 2 YEARS AND 7 MONTHS FROM THE PRIMARY SURGERY REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE SPHERE INSERT FLEX LEFT 13MM S5 WITH A THICKER COMPETITOR POLY TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 10959336 ↗
• InjuryJun 12, 2020Appropriate Device Problem Term/Code Not Available

  PATIENT WAS IMPLANTED IN RIGHT KNEE WITH COMPETITOR PRODUCTS. THEN REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2016 AND REVISION INSERT WAS IMPLANTED. LEFT KNEE PRIMARY SURGERY WAS PERFORMED ON THE (B)(6) 2018, SPHERE INSERT WAS USED. NOW THE PATIENT CAME IN DUE TO SIGNS OF INFECTION IN BOTH KNEES AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A BILATERAL I&D AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10147230 ↗
• InjuryOct 30, 2019Unstable; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY DUE TO LAXITY 2 YEARS AFTER PRIMARY. THE SURGEON REVISED THE MEDACTA SPHERE INSERT FLEX LEFT 13MM S5 WITH A MEDACTA SPHERE INSERT FLEX LEFT 17MM S5. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9254512 ↗
• InjuryApr 17, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 12 DAYS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8522871 ↗
• InjuryJun 26, 2018Device Dislodged or Dislocated

  REVISION SURGERY AFTER ABOUT 1 MONTH FROM PRIMARY DUE TO PATELLA DISLOCATION IN FLEXION. THE SURGEON REVISED THE LINER.

  Patient problems: Joint Disorder

  MAUDE report 7637653 ↗
• InjuryMar 16, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF ANTERIOR KNEE PAIN. THE SURGEON BELIEVES THAT RESURFACING THE PATELLA WOULD ALLEVIATE THE PAIN. THE SURGEON RESURFACED THE PATELLA AND UPSIZED THE POLY FROM A 13MM TO A 17MM POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CAUSE OF PAIN IS UNKNOWN.

  Patient problems: Joint Disorder

  MAUDE report 7344703 ↗