GMK Primary Total Knee System 02.07.0033RPRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07630030815737), received between Dec 1, 2017 and Jul 9, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PAIN DUE TO THE PATELLA NOT TRACKING PROPERLY AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. AT ABOUT 4 YEARS AND 10 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA PATELLA TO A COMPETITOR PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 25763502 ↗
• InjuryAug 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 YEARS 6 MONTHS AFTER THE PRIMARY, 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 AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22726224 ↗
• InjuryJul 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 7 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE PATELLA, POLY, TIBIAL TRAY, AND FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22539990 ↗
• InjuryJul 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE PATELLA, POLY, TIBIAL TRAY, AND FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22518826 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem

  PATELLAR MOBILIZATION DUE TO PATELLAR BONE NECROSIS. REMOVAL OF PATELLAR IMPLANT WITHOUT REPLACEMENT. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Necrosis

  MAUDE report 12597524 ↗
• InjuryOct 7, 2021Device Dislodged or Dislocated

  PRIMARY MYKNEE KINEMATIC ALIGNMENT MRI PPS BLOCKS PERFORMED ON (B)(6) 2021, DURING THE 2 WEEKS FOLLOW-UP VISIT THE SURGEON NOTICED THAT THE PATELLA IMPLANT WAS DISLOCATING IN THE LAST 20% OF FLEXION ONCE THE PATELLA LEAVES THE GROOVE. NO REVISION SURGERY PLANNED AT THE MOMENT.

  Patient problems: Joint Dislocation

  MAUDE report 12588871 ↗
• InjuryJul 28, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  PATELLA SWAP 7 MONTHS AFTER PRIMARY FOR PATELLA DISLOCATION. THE SURGEON REVISED SUCCESSFULLY THE PATELLA.

  Patient problems: Insufficient Information

  MAUDE report 12237369 ↗
• InjuryJul 26, 2021Unstable

  PATELLA IMPLANT REVISION 2 YEARS AND 6 MONTHS AFTER THE PRIMARY DUE TO PATELLAR PAIN CAUSED BY PATELLA MOBILIZATION (RECOGNIZED THROUGH A SPECT CT). THE SURGEON SUSPECTS, THAT THE FIRST TIME HE CEMENTED THE PATELLA, HE MAY HAVE EXCEEDED THE CEMENTING TIME AND THEREFORE IT MAY BE THAT THE CEMENT WAS NOT SO GOOD ANYMORE.

  Patient problems: Pain

  MAUDE report 12224561 ↗
• InjuryJul 23, 2021Unstable

  PATELLA BONE FRACTURE OCCURRED 2 WEEKS AFTER THE PRIMARY SURGERY. 3 WEEKS AFTER THE PRIMARY A REVISION SURGERY WAS PERFORMED. AN ARTIFICIAL LIGAMENT WAS USED FOR THE FIXATION. THE SURGEON ALLEGED THAT THE PATELLA GUIDE WAS NOT STABLE WHILE THE SURGEON WAS REAMING(PRIMARY SURGERY). THE SURGEON CONSIDERED THE INSTABILITY WAS POTENTIALLY THE ROOT CAUSE OF THIS EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 12216451 ↗
• InjuryJul 12, 2021Device Dislodged or Dislocated

  PATELLA DISLOCATION WAS OBSERVED 3 DAYS AFTER THE PRIMARY AND 6 DAYS AFTER THE PRIMARY AN ADDITIONAL SURGERY WAS PERFORMED. DURING THE ADDITIONAL SURGERY, THE SURGEON CONFIRMED THE JOINT CAPSULE RAPTURE. THE SURGEON SUTURED THE RAPTURED JOINT CAPSULE AND CONFIRMED PATELLA TRACKING.

  Patient problems: Joint Dislocation

  MAUDE report 12148706 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REMOVED ALL THE IMPLANTS, REVISED THEM WITH NEW IMPLANTS, AND ADDED EXTENSION STEMS, OFFSET CONNECTORS AND A TIBIAL CONE 1 YEAR AND 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11551131 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF ANTERIOR KNEE PAIN 2 YEARS AND 3 MONTHS AFTER PRIMARY. THE SURGEON PLANS TO RESURFACE THE PATELLA AND A REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2020 . MORE DETAILS TO FOLLOW ONCE THE CASE HAS BEEN COMPLETED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9591143 ↗
• InjuryDec 5, 2018Unstable

  THE PATIENT CAME IN DUE TO INSTABILITY CAUSED BY A LOOSE PATELLA IMPLANT AFTER ABOUT ONE YEAR FROM PRIMARY SURGERY. THE SURGEON REVISED THE PATELLA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 8133919 ↗
• InjuryDec 1, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CALLED MEDACTA USA COMPLAINING OF PAIN. THE PATIENT SAW ANOTHER SURGEON WHO BELIEVES THE PATELLA MAY BE LOOSE. THE PATIENT IS DISSATISFIED WITH THE PRIMARY SURGEON. FURTHER INFORMATION WILL NOT BE ACCESSIBLE AS THE INFORMATION CAME DIRECTLY FROM THE PATIENT.

  Patient problems: Pain

  MAUDE report 7074512 ↗

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