Skip to content

BIOLOX DELTA HIP SYSTEM 650-1058Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

All models of BIOLOX Delta Hip System (22)

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 00880304521933), received between Jun 26, 2019 and Jun 8, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Fitting Problem” (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
  • Fitting Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1
  • Post Operative Wound Infection1

Recent adverse event reports

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

  • InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    SIT WAS REPORTED THAT THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED (B)(6) 2018. SUBSEQUENTLY, THE PATIENT UNDERWENT SCREW REMOVAL AND HEAD AND LINER EXCHANGE ON (B)(6) 2019 DUE TO SCREW MIGRATION. APPROXIMATELY ONE MONTH LATER, THE PATIENT DEVELOPED A SUPERFICIAL INFECTION AT THE INCISION SITE. SUPERFICIAL IRRIGATION AND DEBRIDEMENT WAS PERFORMED ON (B)(6) 2019. NO PRODUCT WAS EXCHANGED AS THE INFECTION DID NOT PENETRATE THE JOINT SPACE.

    Patient problems: Post Operative Wound Infection

    MAUDE report 11955615 ↗
  • 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 8734964 ↗

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

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

How reports and recalls are matched · Editorial policy · Report an error on this page