GMK Primary Total Knee System 02.07.1205RRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 07630030819933), received between Aug 30, 2018 and May 20, 2026 — classified as 60 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (18 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 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 YEAR AND 2 MONTHS FROM PRIMARY. THE SURGEON REMOVED ALL GMK-SPHERIKA IMPLANTS AND IMPLANTED ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25230406 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 YEAR AND 1 MONTH POST PRIMARY THE SURGEON REVISED ALL COMPONENTS (TIBIAL TRAY, LINER, AND FEMORAL COMPONENT) AND IMPLANTED ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25185358 ↗
• InjuryApr 23, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 7 MONTHS FROM PRIMARY SURGERYAND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED THE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY, THEN IMPLANTED ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24964782 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING TIGHTNESS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED FEMORAL COMPONENT, TIBIAL TRAY AND INSERT (SIZE 5 TO SIZE 4). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 24494907 ↗
• InjuryFeb 24, 2026Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence

  REVISION SURGERY WAS PERFORMED 5 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY DUE TO MEDIAL TIBIAL SUBSIDENCE AND FEMORAL LOOSENING. BOTH COMPONENTS WERE LOOSE AT THE CEMENT MANTLE. ADDITIONALLY, THE INSERT SHOWED SIGNS OF SCORING AND PITTING.

  Patient problems: Aseptic loosening

  MAUDE report 24429836 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL PRIMARY IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER TO TREAT THE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23690770 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY FOR TWO TIMES AND THE CAUSE IS UNKNOWN. THE FIRST EPISODE OCCURRED ON (B)(6) 2024, AT ABOUT 2 YEARS AFTER THE PRIMARY SURGERY WITH MEDACTA PRODUCTS. THE SURGEON REVISED ONLY THE LINER (FROM 14 MM TO 17 MM). THE SECOND EPISODE OCCURRED ON (B)(6) 2025 THE SURGEON REVISED THE INSERT, TRAY, AND FEMUR FROM GMK-REVISION TO GMK-HINGE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 23423786 ↗
• InjuryApr 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2023. 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. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21917680 ↗
• InjuryMar 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 YEARS 9 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFUL.

  Patient problems: Unspecified Infection

  MAUDE report 21695441 ↗
• InjuryFeb 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN (B)(4). THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.)

  Patient problems: Medical device site infection

  MAUDE report 21458161 ↗
• InjuryNov 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY AT ABOUT 1 YEAR AND 4 MONTHS POST PRIMARY DUE TO INFECTION, THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20684039 ↗
• InjurySep 17, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 4 MONTHS FROM THE PRIMARY SURGERY THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20237262 ↗
• InjuryJul 1, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 6 YEARS 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS EXCEPT THE PATELLA TO REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 19642078 ↗
• InjuryApr 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19178698 ↗
• InjuryMar 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. 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 LINER AND PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING AND PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 18977237 ↗
• InjuryFeb 5, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS AND 6 MONTHS FROM 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: Unspecified Infection

  MAUDE report 18639657 ↗
• InjuryDec 5, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO LOOSENING OF CEMENTED TIBIAL AND FEMORAL COMPONENTS, AT ABOUT 1 YEAR 4 MONTHS FROM THE PRIMARY.

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

  MAUDE report 18266627 ↗
• InjuryNov 2, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO SECONDARY PATELLA RESURFACING AND INLAY SWAP (AS PER STANDARD PROCEDURE), AT ABOUT 2 YEARS 3 MONTHS FROM THE PRIMARY. DURING INTRAOPERATIVE CHECK OF PROSTHESIS FIXATION, AFTER LITTLE HAMMERING, FEMORAL COMPONENT CEMENTED AND TIBIAL TRAY FIXED CEMENTED WERE EASY TO TAKE OUT. NO CEMENT ON BACKSURFACE. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR'S SYSTEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18054070 ↗
• InjuryOct 27, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 11 YEARS 6 MONTHS AFTER THE PRIMARY, REVISION SURGERY DUE TO A LOOSE CEMENTED TIBIAL TRAY FIXED. THE SURGEON OBSERVED THAT THE COBALT CEMENT SEEMED TO BE THE LOOSENING FACTOR. THE SURGEON REVISED ALL COMPONENTS TO REVISION COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18020319 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 YEAR AND 11 MONTHS AFTER THE PRIMARY SURGERY, 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 17457135 ↗
• InjuryJul 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022 THE PATIENT HAD A PRIMARY KNEE SURGERY. ON (B)(6) 2022, THE PATIENT REPORTED ANTERIOR KNEE PAIN. THE SURGEON RESURFACED THE NATURAL PATIENT'S PATELLA. PRESENTLY ON (B)(6) 2023, REVISION SURGERY DUE TO CEMENTED TIBIAL TRAY OVERHANGING. PAIN DESCRIBED BY THE PATIENT. NO INFECTION, NO LOOSENING OF THE IMPLANTS. THE SURGEON REVISED SUCCESSFULLY THE TIBIAL COMPONENTS.

  Patient problems: Pain

  MAUDE report 17388872 ↗
• InjuryJul 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO BEING IN EXTREME VALGUS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND ADDED AUGMENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17254289 ↗
• InjuryMay 8, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING. THE SURGEON REVISED THE CEMENTED TIBIAL TRAY AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16884698 ↗
• InjuryApr 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16761476 ↗
• InjuryMar 30, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL TRAY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY ALL COMPONENTS TO GMK-REVISION.

  Patient problems: Implant Pain

  MAUDE report 16644025 ↗

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