GMK Revision Total Knee System 02.07.0617SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030819155), received between Oct 19, 2018 and Oct 21, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 24 DAYS AFTER PRIMARY SURGERY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10710631 ↗
• InjuryApr 7, 2020Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY KNEE SURGERY AND WAS IMPLANTED WITH ALL COMPETITORS COMPONENTS. ON (B)(6) 2017, THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON REVISED ALL THE COMPETITOR COMPONENTS (EXCEPT THE PATELLA) IMPLANTING MEDACTA COMPONENTS. PRESENTLY, ON (B)(6) 2020 (3 YEARS AND 2 MONTHS AFTER PRIMARY), THE PATIENT CAME IN REPORTING INSTABILITY. X-RAYS INDICATED THAT THE PROSTHETIC COMPETITOR PATELLA IMPLANT DISLOCATED FROM THE NATURAL PATELLA BONE. THE SURGEON REVISED THE COMPETITOR PATELLA WITH A MEDACTA PATELLA RESURFACING S2 AND REVISED THE MEDACTA INSERT SEMICONSTRAINED 17MM S6 WITH A MEDACTA INSERT SEMICONSTRAINED 23MM S6. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9932417 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem

  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 AND 4 MONTHS AFTER PREVIOUS SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD A PERVIOUS REVISION OF COMPETITOR PRODUCTS AND THE SURGEON IMPLANTED MEDACTA REVISION, THAT IS WHY THE GMK REV IS BEING REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 9848077 ↗
• InjuryOct 19, 2018Microbial Contamination of Device

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION ONE MONTH AND HALF AFTER PRIMARY SURGERY. THE SURGEON PERFORMED A POLY SWAP WITH WASH OUT. THE PATHOGEN IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 7984652 ↗