BIOLOX OPTION HIP SYSTEM 650-1064Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00880304521926), received between Feb 19, 2020 and Dec 9, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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

• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION.

  Patient problems: Hematoma; Pain; Post Operative Wound Infection

  MAUDE report 23756449 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CLINICAL STUDY, AT THE 5-YEAR FOLLOW-UP APPOINTMENT, THE PATIENT WAS EXPERIENCING PAIN, DIFFICULTY WITH AMBULATION AND COMPLETING DAILY ACTIVITIES; AND WAS DIAGNOSED WITH TENDONITIS. THE PATIENT WAS TREATED WITH ANTI-INFLAMMATORY MEDICATION, PHYSICAL THERAPY, AND A STEROID INJECTION. THE ISSUE WAS CONSIDERED RESOLVED. THREE-MONTHS LATER, IN A FOLLOW-UP APPOINTMENT, THE PATIENT NOTED TEMPORARY RELIEF FROM THE INJECTION BUT IS STILL EXPERIENCING PAIN DURING ACTIVE FLEXION OR ACTIVITY. THE PATIENT IS MAINTAINING CONSERVATIVE TREATMENT MODALITIES AND PHYSICAL THERAPY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 18474713 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bacterial Infection; Impaired Healing; Wound Dehiscence

  MAUDE report 18289777 ↗
• InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME INFECTED POST LEFT HIP REVISION THAT REQUIRED A SECONDARY REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 14520695 ↗
• InjuryMay 24, 2021Device Dislodged or Dislocated; Material Integrity Problem; Device Dislodged or Dislocated; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP ARTHROPLASTY ON (B)(6) 2016. PATIENT DISLOCATED AND WAS REVISED ON (B)(6) 2021. UPON REVISION IT WAS DISCOVERED THE LINER WAS BROKEN. THE HEAD, TAPER SLEEVE AND LINER WERE REMOVED AND REPLACED.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 11869261 ↗
• InjuryFeb 19, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT HIP REPLACEMENT. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO COMPLICATIONS WITH METAL ON METAL IMPLANTS. PATIENT WAS AGAIN REVISED DUE TO LEG LENGTH DISCREPANCY. THIS COMPLAINT IS REPORTING THE REVISION DUE TO THE LEG LENGTH DISCREPANCY. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 9727198 ↗

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-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-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-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