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OsteoMed 375-0003Recalls & reported problems

Osteomed LLC · Hemi Great Toe Implant, Medium · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845694011761), received between Feb 6, 2023 and Feb 6, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Difficult to Insert1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 6, 2023Difficult to Insert; Difficult to Insert

    IT WAS REPORTED DURING A HEMI ARTHROPLASTY PROCEDURE, THE SURGEON STRUGGLED TO GET THE OSTEOMED HEMI GREAT TOE IMPLANT IN. THE SURGEON NOTED THAT THE PUNCH INSTRUMENT WAS SIGNIFICANTLY SMALLER THAN THE IMPLANT, AND THE SURGEON HAD TO SOFTEN THE PUNCHED AREA WITH A K-WIRE AND THEN A DRILL TO GET THE IMPLANT TO FIT IN. IT WAS REPORTED THIS ISSUE PROLONGED THE PROCEDURE BY 20-30 MINUTES, AND IT WAS DIFFICULT TO TELL IF THE IMPLANT WAS TIGHT OR LOOSE WHEN THE SURGEON FINALLY GOT THE IMPLANT SEATED. THIS REPORT IS RELATED TO REPORT NUMBER 2027754-2023-00002 FOR THE PUNCH INSTRUMENT INVOLVED IN THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16309369 ↗

Other PROSTHESIS, TOE, HEMI-, PHALANGEAL devices

All PROSTHESIS, TOE, HEMI-, PHALANGEAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.