GMK Primary Total Knee System 02.07.0410SFRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07630030817663), received between Jul 11, 2018 and Feb 11, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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.

• InjuryFeb 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH FROM THE 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 21354287 ↗
• InjuryMay 3, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 4 YEARS AND 2 MONTHS POST PRIMARY THE SURGEON REMOVED ALL COMPONENTS, PERFORMED A WASHOUT, AND REIMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19236177 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 MONTH 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 18128640 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 YEARS AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN WITH INSTABILITY AND PAIN IN KNEE JOINT WITH GMK PRIMARY INSITU. THE SURGEON REVISED THE LINER (10MM) WITH A THICKER ONE (17MM) AND RESURFACED THE PATELLA BONE.

  Patient problems: Joint Laxity

  MAUDE report 17824444 ↗
• InjuryJul 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEARS AND 9 MONTHS FROM THE FIRST REVISION SURGERY, 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: Unspecified Infection

  MAUDE report 17413803 ↗
• InjuryApr 5, 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. AT 1 DAY AFTER SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16680115 ↗
• InjurySep 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 6 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 15348724 ↗
• InjuryNov 15, 2021Device Dislodged or Dislocated

  THE PATIENT CAME IN 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR'S HEAD AND MEDACTA LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 12811746 ↗
• InjuryNov 15, 2021Fracture

  AT 8 YEARS AND 4 MONTHS AFTER THE PRIMARY, REVISION SURGERY WAS PERFORMED DUE TO STEM AND CUP MOBILIZATION. SINCE 2016 THE PATIENT HAD INCREASING HETEROTROPHIC OSSIFICATION AT THE FEMUR AND RADIOLUCENT LINES AROUND THE FEMORAL STEM NECK AND CUP. DURING THE SURGERY, A SMALL ACETABULAR FRACTURE WAS NOTICED. THE SURGEON REVISED ALL IMPLANTS.

  Patient problems: Bone Fracture(s); Extraskeletal ossification; Inadequate Osseointegration

  MAUDE report 12811729 ↗
• InjuryNov 15, 2021Appropriate Device Problem Term/Code Not Available

  AT 4 MONTHS AFTER THE PRIMARY, 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 12809712 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 7 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A KNEE WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10895796 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER.

  Patient problems: Unspecified Infection

  MAUDE report 10507050 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND DID NOT REVISE ANY IMPLANTS. ON (B)(6) 2020, THE PATIENT CAME IN 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 10013153 ↗
• InjuryJul 11, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO THE PATIENT CAME IN COMPLAINING OF PAIN, THE SURGEON DETERMINED THAT PATIENT HAD AN INFLAMED BURSA. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY.

  Patient problems: Inflammation; Pain

  MAUDE report 7677479 ↗

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