GMK Primary Total Knee System 02.07.0314PSFRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030817267), received between Dec 2, 2019 and Feb 26, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT FROM A 14MM TO A 20MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24454887 ↗
• InjuryMay 6, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 4 YEARS AND 6 MONTHS 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 19249220 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 6 YEARS AND 4 MONTHS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11945800 ↗
• InjuryJun 3, 2021Loosening of Implant Not Related to Bone-Ingrowth

  8 MONTHS AFTER THE PRIMARY THE PATIENT CAME IN REPORTING FLEXION LAXITY AND THE CAUSE IS UNKNOWN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE INSERT HEIGHT (FROM 14MM TO 17MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11930936 ↗
• InjuryApr 9, 2021Unstable

  1 YEAR AND 5 MONTHS AFTER PRIMARY THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE INSERT HEIGHT (FROM 14MM TO 17MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 11641933 ↗
• InjuryDec 2, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 4 YEARS AND 5 MONTHS AFTER THE PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP ON THE PATIENT'S LEFT AND RIGHT KNEE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9393610 ↗

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