Novation 164-02-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862035233), received between Aug 27, 2020 and Aug 27, 2020 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K080980); 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. 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.

• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 16 MONTHS POSTOP THIS (B)(6) Y/O FEMALE¿S INITIAL RIGHT THA, THE HIP BECAME INFECTED AND REVISED. ALL TOTAL HIP DEVICES WERE REMOVED AND INSERTION OF ANTIBIOTIC SPACER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WERE DISPOSED BY HOSPITAL.

  Patient problems: Bacterial Infection

  MAUDE report 10462626 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080980. One submission often covers many models, so check the product and lot details in each record.

• Z-0201-2016 · Sep 23, 2015 · Terminated
  Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation