GMK Primary Total Knee System 02.07.0412PSFRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630030817748), received between Aug 30, 2017 and Jul 16, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER 11 YEARS AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED TO A THICKER POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22518829 ↗
• InjuryApr 9, 2021Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY SURGERY AND WAS IMPLANTED WITH COMPETITOR IMPLANTS. ON (B)(6) 2021, THE PATIENT HAD THE COMPETITOR IMPLANTS REVISED TO MEDACTA IMPLANTS FOR REASONS UNKNOWN. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN PATELLA TENDON. THE CAUSE OF THE TORN PATELLA TENDON IS UNKNOWN. THE SURGEON REPAIRED THE PATELLA TENDON AND REVISED THE INSERT P.S. 12MM S4 WITH A INSERT SEMICONSTRAINED 12MM S4. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11640108 ↗
• MalfunctionDec 21, 2020Unstable

  REVISION SURGERY PERFORMED DUE TO KNEE INSTABILITY.

  Patient problems: Failure of Implant

  MAUDE report 11046850 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem

  TWO YEARS AFTER THE PREVIOUS REVISION SURGERY, THE PATIENT CAME IN REPORTING PAIN. THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED ALL THE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 9769048 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 7 YEARS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PLANS TO PERFORM A WASHOUT AND POLY-SWAP. DURING SURGERY IT WAS DISCOVERED THAT THE KNEE WAS WELL FIXED AND WELL BALANCED SO THERE WAS NO NEED TO SWAP THE LINER. IT TURNS OUT THE PATIENT FRACTURED HIS PATELLA SO THE DOCTOR FIXED THAT AND SAID EVERYTHING ELSE WAS GOOD. INFECTION WAS NOT CONFIRMED AND THEY DID NOT REMOVE ANY IMPLANTS AT ALL.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 9706225 ↗
• InjurySep 26, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 1 YEAR AND 8 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE MEDACTA INSERT 12MM S4 WITH A MEDACTA INSERT 14MM S4. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9122746 ↗
• InjuryMar 28, 2019Unstable

  ON (B)(6) WE WERE INFORMED ABOUT THE REVISION SURGERY PERFORMED THE DAY AFTER DUE TO KNEE INSTABILITY (6 YEARS AND 5 MONTHS AFTER PRIMARY), 12 MM PS INLAY HAS BEEN REVISED WITH A 17MM PS INLAY. AFTER THE REVISION THE KNEE WAS STABLE.

  Patient problems: Joint Disorder

  MAUDE report 8460367 ↗
• InjuryMay 25, 2018Detachment Of Device Component; Loose or Intermittent Connection; Device Operates Differently Than Expected

  ON (B)(6) 2018 WE WERE INFORMED ABOUT A LOOSE INLAY-FIXATION SCREW OF A PRIMARY-PS KNEE; THE PATIENT HAD A TRAUMATIC EVENT. IT IS NOT KNOW IF THE SCREW WAS LOOSE BEFORE THE TRAUMATIC EVENT. REVISION SURGERY PERFORMED ON (B)(6) 2018 DURING SURGERY THEY RECOGNIZED THAT THE KNEE WAS VERY UNSTABLE AND THE LATERAL COLLATERAL LIGAMENT WAS COMPLETELY MISSING; IT IS UNKNOWN IF IT WAS MISSING BEFORE OR IF IT WAS RELATED TO THE TRAUMA. ALSO THE TIBIA PLATEAU WAS SUNKEN. THEY FINALLY IMPLANTED A GMK-HINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7544738 ↗
• InjuryMay 17, 2018Detachment Of Device Component

  THE PATIENT CAME IN COMPLAINING OF PAIN 2 YEARS AND 7 MONTHS AFTER PRIMARY. THE SCREW DISASSOCIATED FROM THE POLY INSERT. THE SURGEON REMOVED THE SCREW ARTHROSCOPICALLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 7522287 ↗
• InjuryAug 30, 2017Inadequacy of Device Shape and/or Size

  THE PATIENT CAME IN COMPLAINING OF KNEE PAIN. THE SURGEON SWAPPED THE POLY FROM A SIZE 4 12 MM TO A SIZE 4 10 MM. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Pain

  MAUDE report 6829704 ↗

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