GMK Primary Total Knee System 02.07.1205LRecalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 07630030819926), received between Oct 6, 2017 and May 13, 2026 — classified as 53 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (15 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 54 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT 5 YEARS AND 6 MONTHS FROM THE PRIMARY PROCEDURE, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY THAT BEGAN DURING PHYSICAL THERAPY. THE PATIENT REPORTED INJURING THE KNEE DURING A PHYSICAL THERAPY SESSION AND STATED THAT PAIN PERSISTED FOLLOWING THE INCIDENT. PREOPERATIVE X-RAYS SUGGESTED LOOSENING OF THE COMPONENTS. INTRAOPERATIVELY, ALL COMPONENTS WERE CONFIRMED TO BE LOOSE, WITH SIGNIFICANT MEDIAL FEMORAL BONE LOSS OBSERVED. THE SURGEON REVISED THE GMK-SPHERE FEMUR, INSERT, AND TIBIAL TRAY TO A GMK-HINGE SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 25160333 ↗
• InjuryApr 30, 2026Implant subsidence

  REVISION SURGERY DUE TO INSTABILITY AFTER ABOUT 1 YEAR AND 10 MONTHS FROM PRIMARY SURGERY. THE SURGEON OBSERVED THAT THE TIBIAL TRAY SUBSIDED INTO THE TIBIA. THE SURGEON REVISED THE TIBIAL TRAY TO A REVISION TIBIAL TRAY WITH AUGMENTS AND STEM AND OFFSET CONNECTOR. THE SURGEON ALSO REVISED THE 12MM 5L INSERT TO AN 11MM 4L INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 25039772 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE PRIMARY LEFT KNEE SURGERY, THE SURGEON WAS IMPLANTING THE TIBIAL TRAY FINAL IMPLANT. UPON IMPLANTING THE TIBIAL TRAY, IT WAS OBSERVED THAT A FRACTURE OCCURRED IN THE ANTERIOR PROXIMAL THIRD OF THE TIBIA. THE FRACTURE WAS 3CM IN LENGTH FROM PROXIMAL TO DISTAL. THE SURGEON IMPLANTED A COMPETITOR SCREW/PLATE CONSTRUCT AS WELL AS AN EXTENSION STEM THAT EXTENDED BEYOND THE FRACTURE. POOR/SOFT BONE QUALITY WAS OBSERVED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 24738812 ↗
• InjuryFeb 26, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 5 YEARS AND 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT FROM GMK-SPHERE TO GMK-REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 24454909 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT REPORTED DISCOMFORT AND INSTABILITY. THE SURGEON IDENTIFIED THAT THE TIBIAL COMPONENT WAS EXCESSIVELY EXTERNALLY ROTATED DUE TO MALPOSITIONING DURING THE PRIMARY SURGERY. THE TIBIAL COMPONENT WAS REVISED WITH INTERNAL ROTATION CORRECTION, AND THE INSERT WAS UPSIZED TO IMPROVE JOINT STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 22714427 ↗
• InjuryJul 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL TRAY AND THE CAUSE IS UNKNOWN. ABOUT 1.5 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE TIBIA (WITH A GMK-REVISION TIBIAL TRAY) AND INSERT (FROM 11 TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO CEMENT WAS FOUND ADHERED TO THE TIBIAL TRAY.

  Patient problems: Pain

  MAUDE report 22563687 ↗
• InjuryJul 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT COMPETITOR PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22410972 ↗
• InjuryMay 21, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  BACK ON (B)(6) 2023, DURING THE PRIMARY RIGHT KNEE SURGERY, THE SURGEON ACCIDENTLY IMPLANTED A LEFT TIBIAL TRAY AND INSERT INTO THE RIGHT KNEE. AFTER CLOSURE, THE SURGEON OPENED THE PATIENT AGAIN, REMOVED THE TIBIAL TRAY AND INSERT AND IMPLANTED RIGHT SIDE TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. AT ABOUT 1 MONTH FROM THE PRIMARY THE PATIENT DEVELOPED AN INFECTION, AND THE LINER WAS REVISED, MDR 3005180920-2023-00445 WAS FILED. NO FURTHER REVISIONS WERE REPORTED.

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

  MAUDE report 22058931 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE LINER. PRESENTLY, ON (B)(6) 2025, THE PATIENT WAS REPORTING DISCOMFORT AND THE INABILITY TO GET FULL FLEXION. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED SUCCESSFULLY COMPETITOR COMPONENTS.

  Patient problems: Loss of Range of Motion

  MAUDE report 22027784 ↗
• InjuryApr 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 6 MONTHS THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 21898244 ↗
• InjuryApr 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 5 YEARS AND 2 MONTHS AFTER 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 SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 21855128 ↗
• InjuryApr 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Medical device site infection

  MAUDE report 21737985 ↗
• InjuryMar 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED A ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21643538 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR 9 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A CEMENTED TIBIAL TRAY LOOSENING AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIA AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21311192 ↗
• InjuryNov 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 3 MONTHS POST-PRIMARY THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20771236 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING LOOSENESS. THE PCL (POSTERIOR CRUCIATE LIGAMENT) WAS FOUND TO BE COMPROMISED, AND THE PATIENT WAS EXTREMELY LOOSE IN THE DRAWER TEST, THEREFORE THE SURGEON REVISED THE FEMUR, INSERT AND TIBIA TO REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Damage to Ligament(s)

  MAUDE report 20544246 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF INSTABILITY IS UNKNOWN. ABOUT 3 MONTHS AND A HALF AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE SPHERE KNEE TO A HINGE KNEE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20022419 ↗
• InjuryJul 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY AT ABOUT 6 YEARS 1 MONTH AFTER THE PRIMARY DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT THAT CAUSED THE WEAR AND TEAR OF THE LINER ON THE MEDIAL SIDE. THE SURGEON REVISED SUCCESSFULLY TIBIAL COMPONENT, INSERT AND FEMORAL COMPONENT.

  Patient problems: Pain

  MAUDE report 19665066 ↗
• InjuryMay 2, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD PAIN DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. AT ABOUT 8 MONTHS POST-PRIMARY THE SURGEON REVISED THE TIBIAL TRAY AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 19228141 ↗
• InjuryJan 16, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR FROM 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 18516284 ↗
• InjuryDec 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON THE (B)(6) 2019, THE PATIENT UNDERWENT A MEDACTA KNEE PRIMARY SURGERY. PRESENTLY, THE PATIENT CAME IN REPORTING PAIN. THE MRI SCAN REVEALED THE COMPETITOR CEMENT (DEPUY HIGH VISCOSITY BONE CEMENT) DETERIORATION. IT IS POSSIBLE THAT, DUE TO THIS EVENT, THE IMPLANTS WERE NO LONGER PROPERLY FIXED TO THE BONE. THE PATIENT HAS BEEN REVISED WITH COMPETITOR IMPLANTS ON AN UNKNOWN DATE.

  Patient problems: Implant Pain

  MAUDE report 18282988 ↗
• InjuryAug 4, 2023Migration; Migration

  REVISION FOR CEMENTED TIBIAL TRAY SUBSIDENCE AT 6 YEARS AND 9 MONTHS POST-PRIMARY. THE TIBIA IMPLANTED DURING PRIMARY WAS UNDERSIZED. GMK HINGE IMPLANTED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17458441 ↗
• InjuryJun 23, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY FOR CEMENTED TIBIAL TRAY LOOSENING 1 YEAR AND 4 MONTHS POST PRIMARY. ALL COMPONENTS WERE REVISED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190245 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 10 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO TEARING OF THE MCL DURING THE PRIMARY AND SUBSEQUENT INSTABILITY. THE SURGEON REVISED THE ALL COMPONENTS FROM GMK-SPHERE TO GMK-HINGE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16900770 ↗
• InjuryApr 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER (FROM 12MM TO 17MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16807318 ↗

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