BIOLOX® Delta Hip System 650-1057Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887868248580), received between Oct 7, 2019 and Dec 5, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

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

• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING RIGHT HIP ISSUES AND PAIN SINCE HIS INITIAL IMPLANTATION. IT IS NOW APPROXIMATELY 11 (ELEVEN) YEARS POST-SURGERY. THE PATIENT REPORTS THE SURGEON IS CONCERNED FOR TRUNNIONOSIS AND METALLOSIS. AN MRI WAS PERFORMED THAT DISPLAYED SMALL CHRONIC BONE FRAGMENTS AT THE GREATER TROCHANTER; OTHERWISE, UNREMARKABLE WITHOUT EVIDENCE OF OSSEOUS ABNORMALITY OR OSTEOLYSIS. ALL PRODUCTS REMAIN IMPLANTED.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 23726010 ↗
• InjuryApr 7, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED 3 MONTHS POST IMPLANTATION PATIENT IS ALLEGEDLY EXPERIENCING HIVES, BURNING, SWELLING AND PAIN INTO THE THIGH. RIGHT HIP REMAINS IMPLANTED. REPLY RECEIVED FROM THE PATIENT: THE HIVES HAVE RETURNED EVEN ON MEDICATION AND HE HAS BEEN ADVISED BY THE DOCTOR TO RAMP UP DOSAGE. PATIENT HAD THE METAL PATCH TESTING OF THE PROSTHETIC AND ALL CAME OUT NEGATIVE FOR ALLERGIES. PATIENT WAS ADVISED BY HIS ALLERGIST TO START ADDITIONAL STEROIDS AND ANOTHER MED TO CONTROL THE HIVES.

  Patient problems: Burning Sensation; Edema; Hypersensitivity/Allergic reaction; Inflammation; Pain; Reaction; Swelling

  MAUDE report 9932321 ↗
• InjuryJan 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT, WHERE THE LINER AND HEAD COMPONENTS WERE REMOVED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient; Unspecified Infection

  MAUDE report 9631496 ↗
• InjuryOct 7, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND SUBSEQUENTLY UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE. THE HOSPITAL DID NOT REPORT ANY FALLS OR TRAUMA PRIOR TO THE REVISION SURGERY. THE PATIENT UNDERWENT EXPLANTATION ON 27/09/2019 AND ON THE SAME DAY PRODUCTS WITH ITEM NUMBERS 650-1061 AND 650-1057 WERE IMPLANTED.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 9161371 ↗

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