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HTR-PMI PM619839Recalls & reported problems

Biomet Microfixation, Inc · Class 2 · Implant

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 00841036238407), received between Mar 6, 2019 and Mar 6, 2019 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K924935); they may or may not involve this specific model.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Bacterial Infection1

Recent adverse event reports

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

  • InjuryMar 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Patient problems: Bacterial Infection

    MAUDE report 8394300 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924935. One submission often covers many models, so check the product and lot details in each record.

  • Z-2751-2016 · Jun 13, 2016 · Terminated
    Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of

Other Implant, Malar devices

All Implant, Malar devices →

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