BIOLOX OPTION HIP SYSTEM 650-1068Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304521902), received between Jun 17, 2019 and Jan 9, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fitting Problem” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K082996); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2023Component or Accessory Incompatibility; Component or Accessory Incompatibility

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120215 ↗
• InjuryMay 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY LEGAL COUNSEL THAT A PATIENT UNDERWENT A LEFT HIP ARTHROPLASTY ON (B)(6) 2016. BY (B)(6) 2017 THE PATIENT BEGAN EXPERIENCING PAIN WHILE WALKING. AFTER A 3D RADIOGRAPHIC DIAGNOSTIC REVEALED A DEFECT OF HARDWARE. SUBSEQUENTLY THE PATIENT WAS REVISED. DURING THE (B)(6) 2017 PROCEDURE, INSPECTION OF THE JOINT SPACE SHOWED THAT THERE WERE MULTIPLE FRAGMENTS OF POLYETHYLENE, THAT THE PROSTHETIC FEMORAL HEAD WAS ARTICULATING WITH THE ACETABULAR SHELL, AND THAT THERE WAS STRIPING OVER THE WEIGHT BEARING PORTION. ALL PRODUCTS WERE REVISED.

  Patient problems: Loss of Range of Motion

  MAUDE report 11805429 ↗
• InjuryJun 26, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED BY THE HOSPITAL THAT DURING A HIP REPLACEMENT PROCEDURE, THE IMPLANT WOULD NOT ASSEMBLE WITH MATING IMPLANT. SUBSEQUENTLY, ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8734901 ↗
• InjuryJun 17, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE SURGEON CLAIMED TITANIUM T6 TAPER DID NOT FIT ON STEM PROPER.

  Patient problems: No Information

  MAUDE report 8702847 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082996. One submission often covers many models, so check the product and lot details in each record.

• Z-3132-2024 · Aug 8, 2024 · Open, Classified
  Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 6
• Z-3133-2024 · Aug 8, 2024 · Open, Classified
  Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1
• Z-0302-2018 · Jun 5, 2017 · Terminated
  CER BIOLOXD OPTION HD 32MM, model # 650-1056
• Z-0301-2018 · Jun 5, 2017 · Terminated
  CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064