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Mectacer Biolox Option Heads 01.29.241ARecalls & reported problems

Medacta International SA · Sleeve Size M · Class 2 · Implant

All models of Mectacer Biolox Option Heads (5)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030809385), received between Sep 3, 2020 and Sep 3, 2020 — 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

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

  • InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 2 MONTHS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, SLEEVE, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unspecified Infection

    MAUDE report 10487423 ↗

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Sources and updates

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