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BIOLOX OPTION HIP SYSTEM 650-1066Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304520158), received between Jun 6, 2019 and Jun 21, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Insufficient Device Problem Information1

Patient problems

  • Ambulation or Postural Difficulties1
  • Pain1
  • Unequal Limb Length1
  • Urinary Tract Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT THA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED SEVERAL TIMES. THE PATIENTS' LEGAL ATTORNEY CLAIMS THAT THE PATIENT CONTINUES TO SUFFER FROM PAIN, LOST MOBILITY AND A LEG LENGTH DISCREPANCY AS A RESULT OF THE REVISION SURGERY ON (B)(6) 2019. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Ambulation or Postural Difficulties; Pain; Unequal Limb Length

    MAUDE report 12031552 ↗
  • InjuryJun 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS TREATED FOR A URINARY TRACT INFECTION 18 DAYS AFTER SURGERY.

    Patient problems: Urinary Tract Infection

    MAUDE report 8673877 ↗

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-0301-2018 · Jun 5, 2017 · Terminated
    CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
  • Z-0302-2018 · Jun 5, 2017 · Terminated
    CER BIOLOXD OPTION HD 32MM, model # 650-1056

Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices →

Sources and updates

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