GMK Primary Total Knee System 02.07.0034RPRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 07630030815751), received between Nov 10, 2017 and Aug 3, 2026 — classified as 41 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 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 42 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  Revision surgery due to patella maltracking and dislocation after about 1 year and 4 months from primary. All knee implants were revised using competitors implants. The primary was performed using MyKnee patient match cutting block.

  Patient problems: Joint Dislocation

  MAUDE report 50114124 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MEDWATCH REPORT WAS ANONYMOUSLY SUBMITTED TO FDA. AFTER UNDERGOING TKA ON BOTH KNEES (ON (B)(6) 2022 RIGHT KNEE, ON (B)(6) 2022 LEFT KNEE), THE PATIENT EXPERIENCED SEVERE PAIN, STIFFNESS, INSTABILITY, SWELLING, AND INFLAMMATION. DESPITE TWO KNEE MANIPULATIONS AND NUMEROUS PHYSIOTHERAPY SESSIONS, THE SYMPTOMS PERSISTED. ANOTHER SURGEON EXAMINED THE PATIENT AND DISCOVERED THAT SHE WAS SEVERELY ALLERGIC TO THE IMPLANT MATERIALS, PARTICULARLY NICKEL, AND THAT THE IMPLANTS WERE LOOSE AND MALPOSITIONED. CONSEQUENTLY, A REVISION SURGERY WAS NECESSARY. THE PATIENT EXPRESSED STRONG DISAPPOINTMENT WITH THE QUALITY OF THE MEDACTA DEVICES AND WITH THE LACK OF SUPPORT RECEIVED FROM THE COMPANY, DESPITE REPEATED ATTEMPTS TO CONTACT THEM VIA PHONE AND MAIL. THIS CASE IS RELATED TO THE LEFT KNEE, WHILE ANOTHER COMPLAINT HAS BEEN OPENED AND REFERS TO THE RIGHT KNEE. MEDWATCH CODE: MW5168966.

  Patient problems: Aseptic loosening; Hypersensitivity/Allergic reaction; Implant Pain; Inflammation

  MAUDE report 22051946 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MEDWATCH REPORT WAS ANONYMOUSLY SUBMITTED TO FDA. AFTER UNDERGOING TKA ON BOTH KNEES ((B)(6) 2022 RIGHT KNEE, (B)(6) 2022 LEFT KNEE), THE PATIENT EXPERIENCED SEVERE PAIN, STIFFNESS, INSTABILITY, SWELLING, AND INFLAMMATION. DESPITE TWO KNEE MANIPULATIONS AND NUMEROUS PHYSIOTHERAPY SESSIONS, THE SYMPTOMS PERSISTED. ANOTHER SURGEON EXAMINED THE PATIENT AND DISCOVERED THAT SHE WAS SEVERELY ALLERGIC TO THE IMPLANT MATERIALS, PARTICULARLY NICKEL, AND THAT THE IMPLANTS WERE LOOSE AND MALPOSITIONED. CONSEQUENTLY, A REVISION SURGERY WAS NECESSARY. THE PATIENT EXPRESSED STRONG DISAPPOINTMENT WITH THE QUALITY OF THE MEDACTA DEVICES AND WITH THE LACK OF SUPPORT RECEIVED FROM THE COMPANY, DESPITE REPEATED ATTEMPTS TO CONTACT THEM VIA PHONE AND MAIL. THIS CASE IS RELATED TO THE RIGHT KNEE, WHILE THERE IS ANOTHER COMPLAINT RELATED TO THE LEFT KNEE. MEDWATCH CODE: MW5168965.

  Patient problems: Aseptic loosening; Hypersensitivity/Allergic reaction; Implant Pain; Inflammation

  MAUDE report 22051945 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING STIFFNESS AT ABOUT 5 MONTHS AFTER THE PRIMARY. REHABILITATION HAS BEEN PERFORMED IN ORDER TO RESTORE THE JOINT MOBILITY.

  Patient problems: Loss of Range of Motion

  MAUDE report 21933168 ↗
• InjuryDec 11, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2017. ON (B)(6) 2020 THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR THAT WAS CAUSED FROM FALLING. THE SURGEON REVISED THE FEMORAL COMPONENT AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE REAL ISSUE WAS THE PATELLA DISLOCATING LATERAL AND HE WAS FOCUSED TO ADDRESS THAT. HE CUT THE PATELLA OUT AND DIDN'T PUT ANOTHER PATELLA IN. THE SURGEON ADDRESSED THE PATELLA TRACKING ISSUES WITH SUTURE AND TISSUE TIGHTENING AND RE-ALIGNMENT AND REVISED THE LINER WITH ONE OF THE SAME THICKNESS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20902528 ↗
• InjurySep 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. AT ABOUT 1 MONTH POST PRIMARY THE SURGEON REVISED THE PATIENT'S PATELLA AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 20254225 ↗
• InjuryJun 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 3 WEEKS 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 19605508 ↗
• InjuryMar 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION FOR PATELLA DISLOCATION. AT 5 MONTHS POST PRIMARY PATELLA AND LINER REVISED. NO KNEE INSTABILITY. THE PATIENT HAD A CLINICAL HISTORY OF PATELLA MALTRACKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18901047 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO THE PATELLA IMPLANT MALTRACKING WITH IMPINGEMENT ON THE LATERAL SIDE OF THE FEMORAL IMPLANT. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18482243 ↗
• InjuryMay 26, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR 11 MONTHS AFTER THE PRIMARY, 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 AND THE INSERT AS PER STANDARD PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17009821 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PATELLA PAIN AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE PATELLA IMPLANT AND IMPLANTED A THICKER POLY (FROM 11MM TO 13MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 16991235 ↗
• InjuryFeb 10, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 3 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AND RADIOLUCENCY WAS NOTICED AROUND THE PATELLA. THE SURGEON REVISED THE PATELLA AND FOUND IT WAS LOOSE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 16349596 ↗
• InjuryJan 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PATELLAR DISLOCATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER, FEMUR AND PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16093804 ↗
• InjuryDec 16, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY FOR PATELLA LOOSENING AT ABOUT 1 YEAR AND 3 MONTHS POST PRIMARY. THE SURGEON REVISED ALSO THE LINER FROM 12 MM TO 14 MM THICKNESS TO RESTORE THE KNEE STABILITY.

  Patient problems: Joint Laxity

  MAUDE report 15994324 ↗
• InjuryAug 24, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR AND 9 MONTH AFTER PRIMARY, REVISION SURGERY FOR PAIN WAS PERFORMED. DURING THE REVISION THE PATELLA IMPLANT WAS FOUND TO BE LOOSE. SURGERY COMPLETED SUCCESSFULLY BY SWAPPING PATELLA AND BY IMPLANTING A THICKER LINER.

  Patient problems: Pain

  MAUDE report 15282565 ↗
• InjuryJul 28, 2022Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Pain

  MAUDE report 15121612 ↗
• InjuryJul 18, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 3 YEARS AND 3 MONTHS POST PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR PATELLA LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS ALSO NOTED A PERIPHERAL METALLOSIS AND RISK OF THE PREMATURE WEAR OF THE FEMUR DUE TO THE PATELLA'S DISPLACEMENT.

  Patient problems: Metal Related Pathology

  MAUDE report 15037296 ↗
• InjuryJul 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER THE PRIMARY SURGERY, IT WAS DISCOVERED THE PATELLA DISLOCATION FROM THE FEMUR. AT ABOUT 3 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL THE IMPLANTS.

  Patient problems: Joint Dislocation

  MAUDE report 14942802 ↗
• InjuryJun 17, 2022Break; Material Rupture

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO FALLING AND RUPTURING THE PATELLA TENDON AND DAMAGING THE COLLATERAL LIGAMENTS. THE SURGEON REVISED ALL IMPLANTS EXCEPT THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON 18 MAY 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A PATELLA TENDON RUPTURE AND THE CAUSE IS UNKNOWN. THE SURGEON REMOVED THE PATELLA IMPLANT AND CLOSED THE PATIENT UP WITHOUT A IMPLANTING A NEW PATELLA IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Fall; Pain

  MAUDE report 14733635 ↗
• InjuryApr 4, 2022Loosening 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 AND THE CAUSE OF THE LOOSE PATELLA IS UNKNOWN. AT 4 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE PATELLA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 13995320 ↗
• InjuryNov 25, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE PATELLA AND THE CAUSE OF THE LOOSE PATELLA IS UNKNOWN. AT 6 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE PATELLA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12874309 ↗
• InjurySep 23, 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. THE CAUSE OF THE LOOSE PATELLA IS UNKNOWN. 3 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE PATELLA AND POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12517835 ↗
• InjuryJun 2, 2021Appropriate Device Problem Term/Code Not Available

  DISLOCATION OF THE RESURFACING PATELLA AFTER PRIMARY SURGERY PERFORMED ON (B)(6) 2020. REVISION SURGERY HAS NOT BEEN PLANNED YET.

  Patient problems: Joint Dislocation

  MAUDE report 11919335 ↗
• MalfunctionJun 2, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Joint Dislocation

  MAUDE report 11919187 ↗
• InjuryMar 25, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS WITH COMPETITOR HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11568009 ↗

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