BIOLOX® delta Option 650-1056Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887868271380), received between Jan 14, 2022 and Apr 30, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A HIP REVISION PROCEDURE, THE STERILE PACKAGE LABELED FOR A 32 MM MODULAR CERAMIC HEAD WITH AN OPTION SLEEVE (+6) WAS OPENED AND THE MISMATCH BETWEEN THE LABELED CONTENTS AND THE ACTUAL DEVICE WAS IDENTIFIED. THE PACKAGE CONTAINED A NONMODULAR 32 MM CERAMIC HEAD (-3). OBTAINING A CORRECT REPLACEMENT CAUSED A DELAY OF APPROXIMATELY 15 MINUTES. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25039465 ↗
• InjuryJan 15, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REVISION SURGERY DUE TO HEAD DISLOCATION. DURING THE REVISION, ONLY THE REMOVED DELTA CERAMIC HEAD SHOWED SIGNIFICANT DAMAGE, APPROXIMATELY 2 YEARS, 9 MONTHS, AND 9 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 24077741 ↗
• InjuryNov 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 23508746 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Purulent Discharge; Swelling/ Edema; Wound Dehiscence

  MAUDE report 23483962 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ELEVEN DAYS AFTER A LEFT HIP PROCEDURE, THE PATIENT UNDERWENT A REVISION DUE TO PAIN AND CUP INSTABILITY. THE CUP INSTABILITY WAS ATTRIBUTED TO PATIENT POOR BONE QUALITY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18994476 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT: A PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE. PATIENT TOTAL HIP WAS FINE. SUBSEQUENTLY, PATIENT EXPERIENCED ACUTE ONSET OF PAIN AND SQUEAKING. PAIN BECAME SEVERE OVER A WEEK OR SO, HAD TO GO TO CRUTCHES. PATIENT INVOLVEMENT- REVISION SURGERY.

  Patient problems: Pain

  MAUDE report 13257780 ↗