GMK Primary Total Knee System 02.07.0210PSFRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030816482), received between Dec 19, 2018 and Feb 8, 2021 — classified as 3 injuries.

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

• InjuryFeb 8, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN AFTER 5 YEARS AND 8 MONTHS FROM THE PRIMARY SURGERY REPORTING PAIN AND INSTABILITY. THE CAUSE OF THE PAIN WAS A LOOSE PATELLA AND THE CAUSE OF LOOSE PATELLA WAS LINER INSTABILITY. THE SURGEON REVISED THE INSERT (TO A THICKER ONE) AND PATELLA SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11292054 ↗
• InjuryMar 27, 2020Material Fragmentation; Material Fragmentation

  INLAY FIXATION SCREW BREAKAGE DURING PRIMARY SURGERY, THE SCREW BODY REMAINED IN THE TIBIAL TRAY. THE TORQUE-LIMITER SCREWDRIVER USED WAS THE CORRECT ONE. INLAY PS SUBSTITUTED WITH UC THAT NOT NEED THE SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9887601 ↗
• InjuryDec 19, 2018Device Slipped; Unstable

  THE PATIENT CAME IN DUE TO INSTABILITY, 4 YEARS AND 7 MONTHS AFTER PRIMARY SURGERY, CAUSED BY THE SCREW BACKING OUT OF THE INSERT. THE TORQUE LIMITING DRIVER WAS NOT USED IN THE PRIMARY SURGERY. THE SURGEON REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 8178707 ↗

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