Novation 164-01-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862035103), received between Aug 15, 2023 and Aug 15, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 16, 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 15, 2023Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 7 YEARS POST OP INITIAL RIGHT THA, THIS FEMALE PATIENT WAS REVISED DUE TO A PERIPROSTHETIC HIP FRACTURE. EVERYTHING WAS REMOVED. SURGEON CABLED THE FRACTURE AROUND THE STEM. THE CERAMIC HEAD AND LINER WERE EXCHANGED. HE USED A CERAMIC HEAD FROM ZIMMER BIOMET AND A 32MM EHXL LINER FOR THE CROWN CUP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS AVAILABLE. DEVICE ARE NOT RETURNING - DISPOSED AT THE HOSPITAL.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 17549084 ↗

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