GMK Primary Total Knee System 02.07.0512SFRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030818349), received between Oct 5, 2021 and Jul 22, 2024 — classified as 4 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K090988); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (12 TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19790362 ↗
• InjuryJul 13, 2022Unstable

  AT ABOUT 6 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE INSERT STD. 12MM S5 WITH A THICKER ONE (INSERT U.C.14MM S5) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15001037 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AFTER INJURING THEIR MCL AND THE CAUSE IS UNKNOWN. AT 5 YEARS AND 6 MONTHS AFTER PRIMARY THE SURGEON REPAIRED THE MCL AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANTED INSERT: 02.07.0514FUC INSERT U.C. 14MM S5 1904306.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14072306 ↗
• InjuryOct 5, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 3 WEEKS 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 12576741 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090988. One submission often covers many models, so check the product and lot details in each record.

• Z-0266-2018 · Oct 24, 2017 · Terminated
  The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0