GMK Sphere Total Knee System 02.12.0612FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030826979), received between Jul 29, 2019 and Oct 17, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING THE SURGERY, A TIBIAL INSERT 6-11MM (REFERENCE 02.12.0611FL LOT 2337089) WAS FOUND INSIDE THE BOX OF A TIBIAL INSERT 6-12MM LABELED 02.12.0612FL LOT 2337090. ANOTHER BOX OF THE SAME LOT 2337090 WAS OPENED, AND THE SAME ISSUE WAS FOUND (THE BOX CONTAINED 02.12.0611FL LOT 2337089). SURGERY COMPLETED WITH A CR 12 MM INSERT (ANOTHER 12MM FLEX INSERT WAS NOT AVAILABLE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20470211 ↗
• InjuryNov 10, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 3 YEARS AND 9 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 12786105 ↗
• InjuryJul 29, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED AFTER 8 MONTHS FROM THE PRIMARY DUE TO SIGNS OF AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8835133 ↗