GMK Primary Total Knee System 02.07.0414PSFRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030817847), received between Jan 12, 2018 and Nov 8, 2022 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT ORIGINALLY HAD COMPETITOR'S COMPONENTS AND WAS REVISED TO MEDACTA.

  Patient problems: Unspecified Infection

  MAUDE report 15750754 ↗
• InjuryApr 8, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO INFECTION AFTER ABOUT 1 MONTH, THE INLAY HAS BEEN REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 11633973 ↗
• InjuryDec 20, 2020Break

  THE PATIENT HAD PRIMARY KNEE SURGERY AND WAS IMPLANTED WITH COMPETITOR COMPONENTS. ON (B)(6) 2020, THE PATIENT CAME IN FOR REASONS UNKNOWN AND HAD THE COMPETITOR IMPLANTS REVISED WITH MEDACTA. DURING THE REVISION KNEE SURGERY, WHILE THE SURGEON WAS IMPLANTING THE FINAL INSERT IMPLANT, THE SCREW BROKE. THE SURGEON WAS NOT ABLE TO EXTRACT THE BROKEN THREADS AND ENDED UP CEMENTING THE BEARING INTO THE TIBIAL TRAY TO COMPLETE THE CASE. THERE WAS NO DELAY IN THE SURGERY AND A CONSIGNMENT SET WAS UTILIZED. THE SURGERY WAS COMPLETED SUCCESSFULLY. A 6 NM SCREWDRIVER HAS BEEN USED.

  Patient problems: Insufficient Information

  MAUDE report 11043171 ↗
• InjuryDec 11, 2020Loose or Intermittent Connection; Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO KNEE LAXITY. THE SURGEON, 1 YEAR AND 4 MONTHS AFTER PRIMARY, REVISED THE 14MM POLY WITH A 17MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 10989786 ↗
• InjuryMar 26, 2020Fracture; Fracture

  DURING FINAL IMPLANTATION OF A REVISION KNEE SURGERY, THE TIBIAL INSERT SCREW HAD BROKEN OF WHILE THE SURGEON WAS ATTEMPTING TO PUT THE POLY ON WITH THE TORQUE LIMITING DRIVER. AS A RESULT, THE THREADED PORTION OF THE INSERT SCREW WAS STUCK AND COULD NOT BE REMOVED FROM THE BASEPLATE. THE SURGEON HAD TO REMOVE THE POLY AND THE AGENT HAD TO PROVIDE ANOTHER POLY (UC POLY) TO COMPLETE THE CASE. THERE WAS A 10 MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SCREWDRIVER USED IS NOT CORRECT BECAUSE HAS A TOURQUELIMITER OF 6 NM INSTEAD OF THE CORRECT ONE THAT HAS A TOURQUELIMITER OF 3.5 NM.

  Patient problems: No Information

  MAUDE report 9882641 ↗
• InjuryMay 25, 2018Device Slipped

  REVISION SURGERY DUE TO INLAY LOCKING SCREW UNSCREWING AFTER ABOUT 2 YEARS AND 2 MONTHS AFTER PRIMARY. THE SURGEON REFIXATE THE SCREW THROUGH A "MINI-OPEN" APPROACH.

  Patient problems: No Code Available

  MAUDE report 7544761 ↗
• InjuryJan 12, 2018Break; Device Dislodged or Dislocated

  REVISION 5 YEARS AFTER PRIMARY DUE TO SCREW BREAKAGE AND LINER DISLOCATION: THE SURGEON HAD TO REMOVE ALSO THE TIBIAL COMPONENT AS PART OF THE SCREW WAS STUCK INSIDE IT. NEW TIBIAL BASEPLATE WITH STEM AND NEW THICKER LINER IMPLANTED.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 7186041 ↗

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