NA 201-78-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862045263), received between Nov 25, 2019 and Nov 25, 2019 — classified as 1 injury.

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.

• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED DURING TIBIAL PREPARATION OF A INITIAL TKR ON A FEMALE PATIENT, AGE AND WEIGHT UNKNOWN, ONE OF THE TIBIAL PINS WOULD NOT SEEM TO SINK PROPERLY INTO THE BASEPLATE/BONE. THE SURGEON TRIED SEVERAL TIMES WITHOUT SUCCESS WHICH EVENTUALLY LED TO A PLATEAU FRACTURE OF THE TIBIA. IT WAS DISCOVERED AFTERWARDS THAT THE TIBIAL PIN THAT CAUSED THE ISSUE WAS OVERSIZED AND WOULD NOT FIT THROUGH THE PIN HOLES WITHIN THE TRIAL TIBIAL BASEPLATE. THIS OVERSIZED PIN WAS WHAT DIRECTLY CAUSED THE FRACTURE. THE PIN CAME FROM A PACK OF 4 BASEPLATE PINS AS PER THE REGULAR PROCESS. THERE IS A VIDEO ATTACHED IN THE ELECTRONIC FILE.

  Patient problems: Bone Fracture(s)

  MAUDE report 9368574 ↗