GMK 02.12.E004RPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630971261006), received between Nov 14, 2024 and Jun 26, 2026 — classified as 2 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. ADDITIONALLY, THE SURGEON OBSERVED A PATELLA BONE FRAGMENT FLOATING IN THE KNEE WHICH WAS REMOVED. THE CAUSE IS UNKNOWN. THERE WAS NO INDICATIONS OF TRAUMA. AT ABOUT 1 YEAR AND 5 MONTHS POST PRIMARY THE SURGEON REVISED THE S4 RESURFACING PATELLA TO A S3 PATELLA, AND REVISED THE 11MM FLEX 5L INSERT TO A 13MM FLEX 5L INSERT.

  Patient problems: Joint Laxity

  MAUDE report 25632993 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 1 YEAR AND 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATELLA AND UPSIZED THE POLY (FROM 12 TO 17 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20680970 ↗