GMK Primary Total Knee System 02.07.0312SFRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030817182), received between Dec 28, 2017 and Jun 24, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Unstable” (3 reports).

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.

• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 12 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON UPSIZED THE POLY (FROM 12 TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19593368 ↗
• InjurySep 16, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 YEARS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS AND IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15439031 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 2 YEARS AND 8 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 14397651 ↗
• InjuryDec 10, 2020Loose or Intermittent Connection; Unstable

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2012. ON (B)(6) 2013, THE PATIENT CAME IN FOR REASONS UNKNOWN AND HAD THE TIBIAL INSERT STD FIX S.3 / 12 MM REVISED TO A TIBIAL INSERT STD FIX S.3 / 10 MM. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2020 THE REVISED THE PATIENT KNEE DUE TO PAIN DUE TO A LOOSE PATELLA IMPLANT AND INSTABILITY. THE SURGEON REVISED THE PATELLA AND THE TIBIAL INSERT STD FIX S.3 / 10 MM WITH A INSERT U.C. 12MM S3. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10983850 ↗
• InjuryJan 4, 2018Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE CAUSE OF INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE LINER FROM A 12 MM TO A 17 MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7163358 ↗
• InjuryDec 28, 2017Unstable

  THE PATIENT CAME IN FOR A FOLLOW UP. THE SURGEON DETERMINED THE PATIENT WAS UNSTABLE. THE SURGEON HAS SCHEDULED A REVISION FOR (B)(6) 2018 TO SWAP THE INSERT.

  Patient problems: Joint Disorder

  MAUDE report 7150725 ↗

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