POLYAX®FEMORAL PLATE - LEFT 8141-31-112Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868036958), received between Mar 17, 2022 and Mar 17, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT INTERNAL FIXATION OF LEFT DISTAL FEMUR FRACTURE AS WELL AS PROXIMAL TIBIA FRACTURE APPROXIMATELY 5 YEARS AGO WITH LONG LENGTH LATERAL PLATE AND SCREW FIXATION DEVICE. SUBSEQUENTLY, PATIENT FELT A SNAP IN LEG ABOUT 3 YEARS LATER AND UNDERWENT OPEN REDUCTION INTERNAL FIXATION WITH REPAIR OF NONUNION WITH GRAFT. A NEW MULTI HOLE PLATE LIKE THE ONE THAT BROKE WAS INSERTED AS WELL AS ALL SCREW WERE REINSERTED AT THE EXACT SAME POSITIONS. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13792223 ↗