Novation 164-03-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862035325), received between Jul 14, 2022 and Jul 14, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

• InjuryJul 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A MALE PATIENT, INITIAL IMPLANT DATE UNKNOWN, HAD IMPLANTS REMOVED ON THE LEFT SIDE DUE TO INFECTION. ANTIBIOTIC SPACER WAS IMPLANTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE AVAILABLE FOR RETURN.

  Patient problems: Unspecified Infection

  MAUDE report 15014885 ↗

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