Novation 164-02-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862035202), received between Apr 29, 2025 and Apr 29, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryApr 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 121 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS A PAINFUL LEFT HIP WITH OSTEOLYSIS. REVISION OPERATIVE NOTES WERE PROVIDED. POSTOPERATIVE DIAGNOSIS INDICATED A FAILED LEFT HIP. THE SURGEON PERFORMED DEBRIDEMENT OF EXTENSIVE OSTEOLYSIS ON THE ACETABULUM AND TO SOME DEGREE ON THE FEMUR WITH RECONSTRUCTION OF THE ACETABULUM USING ALLOGRAFT AND BONE FILLER. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Osteolysis; Pain; Scar Tissue

  MAUDE report 21930765 ↗

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