GMK Primary Total Knee System 02.07.0036RPRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07630030815775), received between Sep 21, 2018 and Jun 30, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Osseointegration Problem

  REVISION SURGERY AFTER 4 YEARS AND 7 MONTHS DUE TO A LOOSE PATELLA IMPLANT, AND THE CAUSE IS UNKNOWN. THERE ARE NO INDICATIONS OF TRAUMA. THE SURGEON OBSERVED THAT THE PATELLA WAS STILL IN PLACE BUT LOOSE AND EASILY REMOVED. THE SURGEON REVISED THE PATELLA RESURFACING S4 TO A MOTO PATELLA E-CROSS D 35 AND REVISED THE 12MM FLEX6L TIBIAL INSERT TO A 10MM FLEX6L TIBIAL INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Implant Pain; Inadequate Osseointegration

  MAUDE report 25663302 ↗
• InjuryMar 31, 2026Device Appears to Trigger Rejection

  AT ABOUT 3 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION WITH CUTIBACTERIUM ACNES AND INSTABILITY. THE SURGEON PERFORMED A WASHOUT, AND REVISED ALL COMPONENTS FROM GMK-SPHERE TO GMK-REVISION FOR INCREASED STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24738815 ↗
• InjuryMar 3, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 3 YEARS AND 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO OVER ROTATION OF THE KNEE. THE SURGEON OBSERVED THAT THE PATELLA IMPLANT HAD COME FREEAND PERFORMED A REVISION OF THE PATELLA, UPSIZING THE INSERT TO IMPROVE STABILITY AND ADDRESS THE EXCESSIVE ROTATION EXPERIENCED BY THE PATIENT.. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 24494905 ↗
• InjuryJan 21, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 YEAR AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY. IT WAS NOT POSSIBLE TO ACHIEVE THE CORRECT BALANCE OF THE KNEE IN BOTH FLEXION AND EXTENSION. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21197088 ↗
• InjuryOct 9, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20405450 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO THE FEMUR BEING PLACED TOO VALGUS DURING THE PRIMARY SURGERY. THE SURGEON REVISED THE FEMUR AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 17325437 ↗
• InjuryMar 14, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS AND 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO PATELLA FEMORAL PAIN. WHEN THE SURGEON EVALUATED THE PATIENT, HE DETERMINED THAT THE PATELLA HAD LOOSENED. THE SURGEON REVISED THE PATELLA, FEMUR, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 16538008 ↗
• InjuryMar 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 YEARS 7 MONTHS AFTER THE PRIMARY, REVISION SURGERY DUE TO PATELLAR IMPLANT SUBLUXATION. WIDENING OF THE PATELLAR TENDON POSSIBLY FOLLOWING PROGRESSIVE TEARING OF THE INTERNAL PARAPATELLAR ATHROTOMY. NO LOOSENING OF THE IMPLANTS, NO INFECTION, NO TRAUMA. THE SURGEON REVISED SUCCESSFULLY THE PATELLA IMPLANT (SAME SIZE).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16502651 ↗
• InjuryMay 7, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS DETERMINED THAT THE PATIENT NEEDED TO BE CONVERTED BECAUSE THE PATIENTS QUADRICEPS WASN'T STRONG ENOUGH AND WAS CAUSING THE KNEE TO HYPEREXTEND. ALL COMPONENTS WERE REVISED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, 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 PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14317033 ↗
• InjuryApr 25, 2022Migration; Migration

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE PATELLA AND THE CAUSE OF THE LOOSE PATELLA IS UNKNOWN. THE SURGEON REVISED THE PATELLA 5 YEARS AND 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14191709 ↗
• InjuryJun 2, 2021Device Dislodged or Dislocated

  DISLOCATION OF THE RESURFACING PATELLA AFTER THE PRIMARY SURGERY PERFORMED ON (B)(6) 2021. THE REVISION SURGERY HAS NOT PLANNED YET.

  Patient problems: Joint Dislocation

  MAUDE report 11918709 ↗
• InjuryOct 9, 2020Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DO TO A DISLOCATION OF THE PATELLA 1 MONTH AFTER THE PRIMARY SURGERY. THE SURGEON PERFORMED A LATERAL RELEASE AND REVISED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 10654669 ↗
• InjuryFeb 28, 2020Material Discolored; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY IN 2014, AND WAS IMPLANTED WITH COMPETITOR COMPONENTS. ON (B)(6) 2016, THE PATIENT CAME IN TO HAVE THE COMPETITOR PRODUCTS REVISED. THE SURGEON REVISED THE PATIENT WITH MEDACTA COMPONENTS. PRESENTLY, 3 YEARS AND 6 MONTHS AFTER PRIMARY SURGERY, IT HAS BEEN MADE AWARE THAT THE PATIENT IS IN NEED OF A REVISION DUE TO PARTIAL DISLOCATION OF THE PATELLA. THE CAUSE OF THIS IS UNKNOWN. A REVISION SURGERY HAS NOT BEEN SCHEDULED YET. MORE DETAILS TO FOLLOW WHEN INFORMATION BECOMES AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 9768502 ↗
• InjuryJan 10, 2020Material Fragmentation

  REVISION SURGERY PERFORMED DUE TO PAIN CAUSED BY PATELLA BONE FRAGMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY RESURFACING THE PATELLA IMPLANT AND REMOVING THE PATELLA BONE FRAGMENT.

  Patient problems: Pain

  MAUDE report 9575253 ↗
• InjurySep 21, 2018Insufficient Device Problem Information

  THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 2015. THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATIENT WAS SEPTIC. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY AND REVISED THE PATELLA. MDR (2017-00383) WAS FILED. ON (B)(6) 2018 THE PATIENT WAS REVISED AGAIN DUE TO INFECTION, PATHOGEN UNKNOWN. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED A SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 7897535 ↗