Biolox® delta NK560DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963190446), received between Mar 7, 2021 and Mar 7, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Crack” (1 report).

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.

• InjuryMar 7, 2021Crack; Crack

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NK560D - BIOLOX DELTA PROSTH.HEAD 12/14 32MM S. ACCORDING TO THE COMPLAINT DESCRIPTION, THE IMPLANT WAS DIFFICULT TO FIX. THA USING THE METHA STEM WAS CONDUCTED. DURING THE SURGERY, THE DOCTOR RASPED UP TO NUMBER 2 AND INSERTED THE REAL NUMBER 2. WHEN THE HEAD WAS INSERTED AFTER THE REDUCTION, THE DOCTOR FELT A SLIGHT DISCOMFORT. HE LOOKED CLOSELY AND FOUND A CRACK IN THE BACK OF HIS NECK. UPON CLOSE VISUAL INSPECTION, THE FRACTURE LINE EXTENDED TO THE FRONT OF THE LESSER TROCHANTER, AND THE PRODUCT WAS REMOVED. AFTER THAT, IT WAS REPLACED WITH THE BICONTACT STEM. HE CUT THE BONE AGAIN AND PROCEEDED WITH THE RASP. SINCE THERE WAS NO PROBLEM IN FIXING WITH BICONTACT, BICONTACT WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00141 (400502949 + NC292T).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426534 ↗