GMK Primary Total Knee System 02.07.0035RPRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 07630030815768), received between Aug 2, 2017 and Jul 22, 2026 — classified as 35 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (12 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2026Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25904708 ↗
• InjuryMar 10, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY DUE TO A LOOSE PATELLA AND THE CAUSE IS UNKNOWN. NO TRAUMA WAS REPORTED. THE SURGEON REVISED THE MEDACTA PATELLA TO A COMPETITOR PATELLA AND REVISED THE GMK-SPHERE SIZE 5L -10MM INSERT TO A GMK-SPHERE SIZE 5L -12MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 24558227 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 6 YEARS AND 11 MONTHS POST PRIMARY THE SURGEON REVISED THE PATELLA FROM A SIZE 3 TO A SIZE 4, THE TIBIAL TRAY FROM A SIZE 4 TO A SIZE 6, THE GMK-SPHERE FEMUR SIZE 5 TO A GMK-SPHERIKA FEMUR SIZE 5, AND THE INSERT FROM A 13MM SIZE 4 TO A 12MM SIZE 6 TO INCREASE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24558204 ↗
• InjuryNov 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY AT ABOUT 1 YEAR AND 8 MONTHS POST PRIMARY DUE PAIN RELATED TO PATELLA IMPLANT LOOSENING. PATELLA REVISED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 23579951 ↗
• InjuryJul 8, 2025Loosening 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) 2022, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025 THE PATIENT CAME IN REPORTING PAIN AND A BONE SCAN SUGGESTED A LOOSE PATELLA. THE SURGEON REVISED THE PATELLA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 22435818 ↗
• InjuryMar 5, 2025Fracture; Fracture

  REVISION SURGERY DUE TO PATELLA RESURFACING MOBILIZATION, AT ABOUT 1 YEAR 3 MONTHS AFTER PRIMARY. DURING THE REVISION, THE PATELLAR IMPLANT WAS FOUND WITH 3 BROKEN PEGS STILL IN THE BONE. PATELLAR IMPLANT SUCCESSFULLY REVISED.

  Patient problems: Insufficient Information

  MAUDE report 21523852 ↗
• InjuryNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A PAINFUL TIBIA AND THE CAUSE OF THE PAINFUL TIBIA IS UNKNOWN. THE SURGEON REVISED ALL THE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATELLA IMPLANT AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 20808772 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) APRIL 2015. GMK-SPHERE FEMUR, TIBIA AND INSERT IMPLANTED. ON (B)(6) 2016, THE PATIENT HAS BEEN REVISED (COMPLEMENTARY SURGERY) AND PATELLA IMPLANT SIZE 3 HAS BEEN IMPLANTED. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN AND UNDERGONE A REVISION SURGERY BECAUSE OF A FALLING ON (B)(6) 2021 WITH SUBSEQUENT LOOSENING OF THE PATELLA IMPLANT. NO LOOSENING OF THE OTHER COMPONENTS OR INFECTION. IMPLANTATION OF A NEW PATELLA IMPLANT SIZE 3. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND IT WAS SUSPECTED LOOSENING OF PATELLA IMPLANT. RESURFACING OF PATELLA SIZE 3 AND IMPLANTATION OF A NEW SIZE 3. NO LOOSENING OF THE COMPONENTS DETECTED. CHANGING OF THE TIBIAL INSERT WAS DONE AS PREVENTIVE MEASURE. MOREOVER, THE SURGEON DECIDED TO RAISE THE ANTERIOR TIBIAL TUBEROSITY BECAUSE THE PATELLA WAS VERY LOW AND THIS COULD EXPLAIN THE PAIN, ACCORDING TO THE SURGEON OPINION.

  Patient problems: Implant Pain

  MAUDE report 20557968 ↗
• InjuryOct 28, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 4 YEARS AND 2 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATELLA AND REVISED THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 20545101 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD ANTERIOR KNEE PAIN. AT 6 YEARS FROM PRIMARY THE SURGEON REVISED THE PATELLA IMPLANT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 19971360 ↗
• InjuryJul 1, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS 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: Medical device site infection

  MAUDE report 19641830 ↗
• InjuryApr 24, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS AND 7 MONTHS FROM THE PRIMARY, REVISION SURGERY PERFORMED DUE TO PATELLA LOOSENING AND RUPTURE OF THE PATELLAR TENDON. THE PATIENT DIDN'T HAVE ANY TRAUMATIC SHOCK OR FALL. THE SURGEON REVISED THE PATELLA.

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

  MAUDE report 19174411 ↗
• InjuryJul 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 2 YEARS 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN COMPLAINING OF KNEE INSTABILITY. THE CAUSE OF THE KNEE INSTABILITY IS THE RETINACULAR TEAR. THE SURGEON UPSIZED THE POLY AND RESURFACED THE PATELLA IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 17360775 ↗
• InjuryOct 6, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE PATELLA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATELLA AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15550745 ↗
• InjurySep 27, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS FROM PRIMARY SURGERY, THE SURGEON REVISED THE PATIENT'S PATELLA IMPLANT FOR PATELLA LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information; Pain

  MAUDE report 15494300 ↗
• InjurySep 19, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED 1 YEAR 4 MONTHS AFTER THE PRIMARY FOR PATELLA LOOSENING. NO INFECTION. NO TRAUMA DESCRIBED BY THE PATIENT BUT PAINFUL KNEE. NO LOOSENING OF THE OTHER COMPONENTS. THE PRESENCE OF AN OSTEOPHYTE WAS DISCOVERED ON THE X-RAYS THAT APPEARED AT ABOUT 6 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON SUCCESSFULLY REMOVED THE OSTEOPHYTE AND REVISED PATELLA WITH A NEW IMPLANT.

  Patient problems: Pain

  MAUDE report 15444688 ↗
• InjuryFeb 9, 2022Unstable

  PATELLA IMPLANT REVISION AT 1 YEAR AND 2 MONTHS AFTER PRIMARY DUE TO KNEE INSTABILITY AND PATELLA PAIN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13498306 ↗
• InjuryJun 2, 2021Appropriate Device Problem Term/Code Not Available

  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 11919393 ↗
• 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 11918708 ↗
• InjuryJun 2, 2021Malposition of Device; Malposition of Device

  TKA PRIMARY SURGERY PERFORMED USING MYKNEE DEVICES FOR THE POSITIONING OF THE THE FEMORAL COMPONENT, TIBIAL TRAY AND THE RESURFACING PATELLA. NO ISSUE IN PER-OPERATIVE WAS NOTED THEN. A POST-OP CONTROL X-RAY INDICATED A DISLOCATION OF THE RESURFACING PATELLA AND A FEMORAL ROTATION OF 8¿. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 (6 MONTHS AFTER PRIMARY). ONLY THE FEMORAL COMPONENT WAS REMOVED.

  Patient problems: Joint Dislocation

  MAUDE report 11918707 ↗
• InjuryMay 26, 2021Unstable; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATED PATELLA. THE CAUSE OF THE DISLOCATED PATELLA IS UNKNOWN. THE SURGEON PERFORMED AN OSTEOTOMY OF THE TIBIA TO CHANGE TRACKING AND REVISED THE INSERT WITH A 17MM ONE THE DAY AFTER PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS A BIT OF INSTABILITY AND THE SURGEON WANTED TO GIVE THE PATIENT MORE STABILITY SO HE UPSIZED THE POLY AND, INSTEAD OF USING AUGMENTS, THE SURGEON PERFORMED A TIBIAL OSTEOTOMY AND USED HIP SCREWS TO HOLD IT BACK TOGETHER.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 11884443 ↗
• InjuryMay 25, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD A PRIMARY KNEE SURGERY AND WAS IMPLANTED WITH COMPETITOR IMPLANTS. ON (B)(6) 2019, THE PATIENT HAD THE COMPETITOR IMPLANTS REVISED TO MEDACTA IMPLANTS FOR REASONS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT CAME IN REPORTING PAIN DUE TO A PATELLA DISLOCATION AND THE CAUSE OF THE PATELLA DISLOCATION IS UNKNOWN. 1 YEAR AND 6 MONTHS AFTER MEDACTA IMPLANT INSERTION THE SURGEON REVISED THE FEMORAL COMPONENT, INSERT, AND ADDED EXTENSION STEM, DISTAL FEMORAL WEDGE, AND POSTERIOR FEMORAL WEDGE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 11877232 ↗
• InjuryMay 6, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  4 MONTHS AFTER IMPLANTATION OF THE PATELLA IMPLANT, IT WAS REVISED WITH THE COMPETITOR PRODUCT DUE TO PAIN, PATELLA IMPLANT MOBILIZATION AND INSTABILITY. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2016 AND THE PATELLA IMPLANT WAS INSTALLED ON (B)(6) 2020. PROBABLY ALSO THE LINER WAS REVISED, BUT IT CAN'T BE CONFIRMED. THERE WAS NO PROBLEM WITH THE LINER.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11782203 ↗
• InjuryMar 29, 2021Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE PATELLA IMPLANT AND THE CAUSE OF THE LOOSE PATELLA IS UNKNOWN. 8 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATELLA IMPLANT AND THE LINER SUCCESSFULLY. THE TIBIAL INSERT WAS NOT THE SOURCE OF PAIN BUT THE SURGEON FELT THAT IT WOULD BE BETTER IF THE SIZE WAS INCREASED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11582050 ↗
• InjuryJan 11, 2021Loosening 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 PATELLA IMPLANT. 1 YEAR AND 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATELLA IMPLANT AND POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11147524 ↗

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