GMK Primary Total Knee System 02.07.0410FUCRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030817618), received between Jul 14, 2017 and Jun 17, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 12 YEARS 10 MONTHS, 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: Medical device site infection

  MAUDE report 22229293 ↗
• InjuryFeb 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 8 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16349597 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 7 YEARS AND 2 MONTHS FROM THE PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14247702 ↗
• InjuryJun 7, 2021Unstable

  9 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE TIBIAL INSERT U.C. FIX S.4 / 10 MM WITH AN INSERT U.C. 14MM S4 TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11946159 ↗
• InjuryMay 14, 2019Appropriate Device Problem Term/Code Not Available

  ADDITIONAL SURGERY PERFORMED 5 YEARS AND 1 MONTH AFTER THE PRIMARY DUE TO KNEE INFECTION. THE KNEE WAS WASHED OUT.

  Patient problems: Unspecified Infection

  MAUDE report 8607923 ↗
• InjuryJan 16, 2019Patient-Device Incompatibility

  ON "DEC 17", 2018 WE WERE INFORMED ABOUT A PATIENT WHO CAME IN DUE TO LAXITY. ON THE FOLLOWING DAY, THE SURGEON REVISED THE, POLY, TIBIAL TRAY AND FEMORAL COMPONENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8252590 ↗
• InjuryJan 16, 2019Microbial Contamination of Device

  ABOUT 6 YEARS AND 2 MONTHS AFTER PRIMARY THE SURGEON PERFORMED AN I&D AND LINER SWAP ON BOTH KNEES FOR AN INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATHOGEN IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 8252587 ↗
• InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 5 YEARS AFTER THE PRIMARY SURGERY (10 MONTHS AFTER THE PREVIOUS SURGERY PERFORMED BY COMPETITOR). THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP ON BOTH KNEES AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NOTE: THE PATIENT HAD A PRIMARY TKA ON BOTH HIS LEFT AND RIGHT KNEE IN 2013. THE PATIENT HAD A SPINAL PROCEDURE PERFORMED BY A COMPETITOR IN 2018 THAT LED TO BOTH KNEES BECOMING INFECTED. LEFT KNEE: (B)(6) 2013, ALAMANCE REGIONAL MED CTR, MD MICHAEL MENZ: (LOT 121454). RIGHT KNEE: (B)(6) 2013, ALAMANCE REGIONAL MED CTR, MD MICHAEL MENZ: (LOT 120150).

  Patient problems: Unspecified Infection

  MAUDE report 8221849 ↗
• InjuryOct 25, 2018Insufficient Device Problem Information

  REVISION SURGERY PERFORMED DUE TO SIGNS OF INFECTION 2 YEARS AND HALF AFTER PRIMARY SURGERY. THE PATHOGEN IS UNKNOWN. THE POLY WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 8004512 ↗
• InjuryMar 7, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN 6 YEARS AFTER PRIMARY. THE CAUSE IS UNKNOWN. THE SURGEON SWAPPED THE INSERT WITH A NEW ONE OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 7319697 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED DUE TO SIGNS OF INFECTION ABOUT 7 YEARS AFTER PRIMARY. THE PATHOGEN IS UNKNOWN. THE WASHED OUT THE KNEE AND SWAPPED THE INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 7251041 ↗
• InjuryJul 14, 2017Unstable

  THE PATIENT CAME IN COMPLAINING OF PAIN AND INSTABILITY. THE CAUSE OF THE PAIN AND INSTABILITY IS UNKNOWN. THE SURGEON PLANS TO REVISE THE POLY AND POSSIBLE REVISION OF THE PATELLA. THE REVISION IS SCHEDULED FOR (B)(6) 2017.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6714007 ↗

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