BIOLOX® Delta Hip System 650-1058Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887868248597), received between Oct 8, 2019 and Feb 23, 2021 — classified as 4 injuries.

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

• InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 11 MONTHS POST IMPLANTATION DUE TO AN INFECTION. NO ADDITIONAL INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 11365257 ↗
• InjuryNov 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION OF THE HEAD AND LINER DUE TO INFECTION

  Patient problems: Unspecified Infection

  MAUDE report 9303573 ↗
• InjuryOct 14, 2019Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  PATIENT UNDERWENT PRIMARY LEFT THA. SUBSEQUENTLY, THE PATIENT EXPERIENCED A DISLOCATION AND CLOSED REDUCTION WAS PERFORMED.

  Patient problems: Joint Dislocation

  MAUDE report 9184257 ↗
• InjuryOct 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY LEFT THA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ORTHOSTATIC HYPOTENSION AND THIS DELAYED THE PATIENTS DISCHARGE FROM THE HOSPITAL. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 9165937 ↗

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