GMK Primary Total Knee System 02.07.0310PSFRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07630030817069), received between Oct 26, 2017 and Mar 13, 2026 — classified as 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 4 MONTHS FROM PRIMARY,THE PATIENT CAME IN DUE TO HAVING AN UNUSUAL MASS OF SOFT TISSUE/FLUID LOCATED AT THE QUADRICEPS AND THE CAUSE IS UNKNOWN. THE SURGEON DRAINED AND WASHED OUT THE KNEE, THEN REVISED THE INSERT FROM A PS 10MM TO A SEMICONSTRAINED 12MM DUE TO LAXITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 24596903 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN PRESENTING INSTABILITY DUE TO A LOOSE KNEE IN FLEXION AND THE CAUSE IS UNKNOWN. ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT FROM A 10MM SIZE 3 TO A 14MM SIZE 3 TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24558199 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 7 YEARS 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23758556 ↗
• InjuryMay 17, 2024Fracture; Fracture

  THE SCREW OF THE PS INSERT BROKE BEFORE THE TORQUE LIMITER SCREWDRIVER 3.5 NM (REF 02.07.10.4577) REACHED THE CLICK. THE SURGEON REMOVED THE IMPLANT, RECUT TO REMOVE THE CEMENT AND PLACED NEW IMPLANTS. SURGERY COMPLETED WITH 30 MIN DELAY.

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

  MAUDE report 19341857 ↗
• InjuryJan 12, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY WITH COMPETITOR DEVICES ON UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED FOR AN UNKNOWN REASON ON THE (B)(6) 2023 AND MEDACTA DEVICES WERE IMPLANTED. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18501915 ↗
• InjuryFeb 9, 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 ABOUT 9 YEARS AND 2 MONTHS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16334660 ↗
• InjuryJun 3, 2022Break; Break

  THE INSERT SCREW BROKE WHILE USING A WRONG SCREWDRIVER. IT WAS DECIDED TO REMOVE THE CEMENTED TIBIAL TRAY AND THE INSERT AND REPLACE THEM WITH THE SAME RANGE OF PRODUCTS IN ORDER TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 14591430 ↗
• MalfunctionFeb 10, 2022Fracture; Fracture

  THE EXTENSION STEM SCREW BROKE DURING SURGERY. THE SURGEON HAD TO REMOVE THE CEMENTED TIBIAL TRAY ON THE PATIENT TO CHANGE IT TO ANOTHER CEMENTED TIBIAL TRAY, THE LINER WAS ALSO CHANGED. THE LOCKING SCREWDRIVER USED WAS THE TORQUE LIMITER WRENCH OF 6 NM.

  Patient problems: Insufficient Information

  MAUDE report 13505001 ↗
• InjuryJul 2, 2021Break; Break

  DURING TKA, THE INSERT LOCKING SCREW BROKE IN 2 PARTS. ONE PART WAS IN THE LINER PE AND THE OTHER PART IN THE TIBIAL BASEPLATE. THE SURGEON REMOVED ALL THE PARTS OF TIBIAL COMPONENTS (LINER, TIBIAL BASEPLATE, AND EXTENSION STEM) AND REPLACED THEM WITH SAME SIZE. A 6 NM REVISION SCREWDRIVER HAS BEEN USED.

  Patient problems: Insufficient Information

  MAUDE report 12107465 ↗
• InjuryJul 3, 2020Migration; Migration

  REVISION SURGERY PERFORMED 7 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO INLAY LOCKING SCREW UNSCREWING. THE LINER WAS REPLACED.

  Patient problems: No Code Available

  MAUDE report 10229313 ↗
• InjuryDec 5, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP 1 YEAR 5 MONTHS AND A HALF AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9416241 ↗
• MalfunctionNov 27, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  DURING AN AMBULANCE VISIT IN THE HOSPITAL LKH-STOLZALPE ON (B)(6) 2019, THE PHYSICIAN DR. (B)(6) DETECTED THE LOOSE INLAY FIXATION SCREW IN THE BACK OF THE JOINT ON THE X-RAY PICTURES. REVISION SURGERY HAS BEEN THEN PERFORMED, MORE THAN 6 YEARS AFTER PRIMARY SURGERY. ALL COMPONENTS HAVE BEEN SUCCESSFULLY REVISED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9383331 ↗
• InjuryApr 24, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY AFTER ONE MONTH FROM THE PRIMARY DUE TO SIGNS OF INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED AN I&D AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8544431 ↗
• InjuryApr 16, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 6 YEARS AFTER PRIMARY SURGERY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8518690 ↗
• InjuryNov 6, 2018Device Slipped

  THE PATIENT CAME IN COMPLAINING OF PAIN 4 YEARS AND A HALF AFTER PRIMARY. THE SURGEON DETERMINED THAT THE SCREW BACKED OUT OF THE POLY (RIGHT KNEE). THE SURGEON REMOVED THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8041545 ↗
• InjuryMar 16, 2018Insufficient Device Problem Information

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION IN BOTH KNEES. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I & D AND SWAPPED THE POLY ON BOTH SIDES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7344704 ↗
• InjuryDec 6, 2017Device Operates Differently Than Expected

  THE PATIENT HAD A PRIMARY SURGERY WITH MYKNEE IN (B)(6) 2016. THE PATIENT WAS UNABLE TO COMPLETE PHYSICAL THERAPY DUE TO ILLNESS. THE PATIENT CAME IN COMPLAINING OF STIFFNESS. ON (B)(6) 2017 THE SURGEON REMOVED/RELEASED THE SOFT TISSUE THAT HAMPERED FLEXION AND SWAPPED THE INSERT.

  Patient problems: Joint Disorder

  MAUDE report 7086824 ↗
• InjuryOct 26, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNAVAILABLE. THE SURGEON PERFORMED AN I&D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 6979318 ↗

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