Novation 164-03-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862035301), received between Mar 9, 2021 and Apr 29, 2025 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT, INITIAL LEFT HIP IMPLANTED IN (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE. ELEMENT STEM REVISED TO COMPETITOR¿S STEM, POTENTIALLY DUE TO FEMORAL BONE FRACTURE FROM RADIOGRAPH PROVIDED. NO FURTHER INFORMATION KNOWN.

  Patient problems: Insufficient Information; Limb Fracture

  MAUDE report 21930553 ↗
• InjuryMar 9, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE (B)(6) Y/O MALE PATIENT HAD UNDERSIZED, VARUS STEM THAT HAD BECOME LOOSE (ASEPTIC). SURGEON REMOVED THE STEM AND CUP AND IMPLANTED A SROM STEM AND ZB G7 DUAL MOBILITY CUP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT FOR EVALUATION DUE TO FACILITY POLICY.

  Patient problems: Failure of Implant

  MAUDE report 11446575 ↗

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