PROstep™ MIS Bunionette 977TIMPMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889797075985), received between May 12, 2022 and May 12, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 16, 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.

• InjuryMay 12, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY THE PATIENT THAT,"YOUR PROSTEP MEDULLARY ROD TOGGLES IN THE METATARSAL BONE SHAFT, DESTROYING MY METATARSAL BONE. I NEED BONE GRAFTING. THE SCREW THAT SHOULD HAVE BEEN SECURED IN THE DISTAL OSTEOTOMY SEGMENT WAS IN SOFT TISSUE CAUSING NONUNION AND AVN. I DEVELOPED EXTREME PAIN AND A PALPABLE SCREW HEAD. THE INTRAMEDULLARY IMPLANT WAS LOOSE AND TOGGLING AS EARLY AS POST OP WEEKS 1 AND 3. THE PODIATRIST WOULD NOT DISCLOSE THE PROBLEM UNTIL I DISCOVERED IT AT WEEK 16. I WILL HAVE NUMEROUS SURGERIES REVISIONS AND BONE GRAFTING PATIENT WILL HAVE A REVISION ON (B)(6) 2022 TO HAVE A SCREW REMOVED AND HAVE THE ROD OUT OF METATARSAL SHAFT."

  Patient problems: Implant Pain; Necrosis

  MAUDE report 14380620 ↗