Novation 164-03-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862035288), received between May 30, 2022 and May 30, 2022 — 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.

• InjuryMay 30, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7.5 YEARS POST INITIAL RIGHT THA, THE FEMALE PATIENT WAS BROUGHT BACK FOR RIGHT HIP PAIN. SIGNS OF OSTEOLYSIS AND A LOOSE STEM. THE HIP WAS DISLOCATED, THE FEMORAL HEAD REMOVED, STEM CHECKED FOUND LOOSE AND REMOVED. ATTENTION TURNED TO CUP. LINER WAS REMOVED WITH A CHISEL, THE BONE SCREW WAS REMOVED. THE CUP WAS CHECKED AND FOUND TO BE WELL FIXED. A NEW XLE LINER WAS IMPLANTED ALONG WITH A HPS STEM. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND X-RAYS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS PATIENT ASKED TO KEEP IMPLANTS.

  Patient problems: Failure of Implant

  MAUDE report 14545126 ↗

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