GMK Total Knee System 02.12.KA13RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630345716224), received between Apr 24, 2025 and Aug 26, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY, WITH SUBSEQUENT POSTOPERATIVE HEALING DIFFICULTIES. AT THE MOST RECENT FOLLOW-UP, THE PATIENT REPORTED WORSENING PAIN ASSOCIATED WITH INTERNAL INSTABILITY, ALONG WITH MARKED PAIN IN THE TIBIAL METAPHYSIS AND THE FEMOROPATELLAR JOINT. AT 11 MONTHS FROM THE PRIMARY, REVISION SURGERY WAS PERFORMED IMPLANTING A SEMI-CONSTRAINED KNEE PROSTHESIS. INTRAOPERATIVE SAMPLES CONFIRMED THE PRESENCE OF CHRONIC PERIPROSTHETIC INFECTION.

  Patient problems: Medical device site infection; Pain

  MAUDE report 22894250 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT FROM TO MORE COSTRAINED COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21975203 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED STIFFNESS. ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE STIFFNESS WAS TREATED UNDER ANESTHESIA WITH MANIPULATION, BUT NO COMPONENT WAS REVISED.

  Patient problems: Loss of Range of Motion

  MAUDE report 21897617 ↗