GMK Sphere Total Knee System 02.12.0214FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030826214), received between Jan 26, 2018 and Aug 28, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY (FROM 12 TO 20 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20085910 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. AT ABOUT 8 MONTHS FROM PRIMARY THE SURGEON REVISED THE INSERT AND RESURFACED THE PATIENT'S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16276067 ↗
• InjuryNov 3, 2020Appropriate Device Problem Term/Code Not Available

  PATIENT WAS EXPERIENCING INSTABILITY AND ANTERIOR KNEE PAIN FROM CHRONIC TENDINOPATHY. 11 MONTH AFTER PRIMARY THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT - FLEX S2L -14MM WITH A GMK-SPHERE TIBIAL INSERT - FLEX S2L - 20MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10778506 ↗
• InjuryOct 30, 2020Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. 1 YEAR AND 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE GMK-SPHERETIBIAL INSERT - FLEX S2L - 14 MM WITH A GMK-SPHERETIBIAL INSERT - FLEX S2L - 17MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 10761314 ↗
• MalfunctionMay 29, 2019Packaging Problem; Packaging Problem

  DURING THE PACKAGING OPENING IT WAS NOTICED THAT THE BAG CONTAINING THE INSERT INSIDE THE BLISTER WAS OPEN. THE SURGEON DECIDED TO USE A NEW IMPLANT TO COMPLETE THE SURGERY. THE IMPLANT WAS IN THE HOSPITAL AS CONSIGNMENT.

  Patient problems: No Information

  MAUDE report 8649826 ↗
• InjuryJan 26, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO SUPERFICIAL INFECTION AT THE INCISION SITE, THAT COMMUNICATE WITH THE JOINT, 22 DAYS AFTER PRIMARY. THE SURGEON WASHED OUT THE INFECTION AND REPLACED THE POLY WITH A SIZE2X14MMM LEFT POLY. THE SURGEON INSERTED THE POLY INCORRECTLY (LOT 163355), AT WHICH TIME THE LOCKING MECHANISM WAS DAMAGED. AN INSERT FROM ANOTHER LOT WAS OPENED AND INSERTED WITHOUT FURTHER DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 7221025 ↗
• InjuryJan 26, 2018Device Slipped

  INLAY LOCKING SCREW ARTHROSCOPIC REMOVAL DUE TO UNSCREWING. TORQUE LIMITING SCREWDRIVER WAS NOT USED IN PRIMARY SURGERY.

  Patient problems: No Code Available

  MAUDE report 7221024 ↗