GMK Sphere Total Knee System 02.12.0512FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 07630030826771), received between Feb 14, 2018 and Oct 31, 2025 — classified as 32 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 4 MONTHS POST PRIMARY THE SURGEON UPSIZED THE POLY FROM 11MM TO 14MM FOR STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23436204 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 YEARS AND 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE LINER (12MM) WITH A THICKER ONE (13MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20124855 ↗
• InjuryMar 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 3 YEARS 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: Unspecified Infection

  MAUDE report 18957392 ↗
• InjuryMar 29, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16633974 ↗
• InjuryJan 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 10 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 16157354 ↗
• InjuryDec 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 YEAR AND 6 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16021047 ↗
• InjurySep 13, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  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 15409155 ↗
• InjuryAug 5, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY AT ABOUT 5 MONTHS FROM PRIMARY FOR KNEE INSTABILITY. THE SURGEON SWAPPED THE LINER TO A THICKER ONE SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 15174143 ↗
• InjuryJul 27, 2022Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. AT ABOUT 2 YEARS AND 5 MONTHS FROM PRIMARY THE SURGEON REVISED THE LINER WITH A THICKER ONE TO GIVE MORE STABILITY TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15112215 ↗
• InjuryJun 28, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A MEDIAL RETINACULUM REPAIR AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14840039 ↗
• InjuryJun 28, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AND A HALF 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 14839995 ↗
• InjuryMay 9, 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 13 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14336936 ↗
• InjuryApr 5, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 7 MONTHS AFTER PRIMARY DUE TO INSTABILITY. THE LINER HAS BEEN REVISED AND A THICKER ONE IMPLANTED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 14010943 ↗
• InjuryDec 22, 2021Unstable

  AT 2 YEARS 11 MONTHS AFTER THE SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (12 MM TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13060219 ↗
• InjuryNov 22, 2021Appropriate Device Problem Term/Code Not Available

  ABOUT A 1 MONTH AND A HALF AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS STAPHYLOCOCCUS. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bacterial Infection

  MAUDE report 12852346 ↗
• InjuryAug 2, 2021Appropriate Device Problem Term/Code Not Available

  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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12258065 ↗
• InjuryJul 13, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO DEVELOPING A HEMATOMA 15 DAYS AFTER PRIMARY AND THE CAUSE OF THE HEMATOMA IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hematoma

  MAUDE report 12157572 ↗
• InjuryJul 12, 2021Appropriate Device Problem Term/Code Not Available

  2 WEEKS 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 12149876 ↗
• InjuryApr 21, 2021Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED 12MM INSERT WITH 13MM ONE 2 YEARS AND 5 MONTHS AFTER PRIMARY, TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11700218 ↗
• InjuryMar 10, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY 1 MONTH AND 1 WEEK AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11451745 ↗
• InjuryJun 26, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING AN INABILITY TO ACHIEVE FULL EXTENSION AFTER HEARING A POPPING SOUND DURING REHAB. 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE FEMORAL COMPONENT, RESECTED MORE THE DISTAL FEMUR AND REVISED THE INSERT TO A THINNER ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REASON OF POPPING SOUND IS UNKNOWN.

  Patient problems: Joint Disorder

  MAUDE report 10198975 ↗
• InjuryJun 4, 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 REMOVED ALL IMPLANTS AND PERFORMED A WASHOUT. A FEMORAL AND TIBIAL COMPONENT WERE IMPLANTED ALONG WITH ANTIBIOTIC CEMENT. THE SURGEON WILL IMPLANT PERMANENT HARDWARE AT A LATER DATE THAT HAS YET TO BE DETERMINED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10117916 ↗
• InjuryMar 9, 2020Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. 2 YEARS AFTER PRIMARY THE SURGEON REVISED THE SPHERE INSERT FLEX LEFT 12MM S5 WITH A 14MM S5. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9804582 ↗
• InjuryDec 2, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY DUE TO LOOSE LIGAMENTS. THE SURGEON REVISED THE 12MM LINER WITH A 17 MM ONE 6 MONTHS AND A HALF AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9394134 ↗
• InjuryOct 8, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 8 MONTHS AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON REVISED THE INSERT SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9165823 ↗