GMK Primary Total Knee System 02.07.0510SFRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630030818240), received between Dec 21, 2018 and Sep 5, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 9 YEARS AND 10 MONTHS AFTER 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: Medical device site infection

  MAUDE report 20143205 ↗
• InjuryAug 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. ON (B)(6) 2023, 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. PRESENTLY, ON (B)(6) 2023, THE SURGEON REPORTS THAT THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IS PRESENTING SIGNS OF AN INFECTION. THE SURGEON REVISED THE TIBIAL TRAY, INSERT, FEMORAL COMPONENT AND PATELLA COMPONENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17649538 ↗
• InjuryMar 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 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 16564950 ↗
• InjuryMar 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 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 16545757 ↗
• InjuryFeb 9, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 1 MONTH AFTER THE PRIMARY SURGERY 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 11300314 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED AFTER 15 DAYS FROM THE PRIMARY SURGERY DUE TO INFECTION. THE SURGEON REVISED THE INSERT AND PERFORMED A WASHOUT (DIAR). THERE WAS NO CULTURES GROWTH FROM THE SWABS TAKEN BUT CLINICALLY THE PATIENT HAS AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10905718 ↗
• InjuryFeb 11, 2020Microbial Contamination of Device

  REVISION SURGERY PERFORMED 3 MONTHS AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9693700 ↗
• InjuryJun 12, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2018 (3 MONTHS AFTER THE PRIMARY SURGERY) DUE TO SIGNS OF INFECTION AND THE SURGEON SUBSEQUENTLY PERFORMED AN I&D AND POLY-SWAP (EMDR 2018-01035 WAS FILED). PRESENTLY, 6 MONTHS AFTER LAST REVISION SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON REVISED THE TIBIAL TRAY, FEMORAL COMPONENT AND POLY ON (B)(6) 2019. WE WERE ALERTED ON (B)(6) 2019. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8691474 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem

  ABOUT 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR INFECTION. AN I&D WAS PERFORMED AND THE LINER WAS SWAPPED SUCCESSFULLY. THE PATHOGEN IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 8188870 ↗

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