BIOLOX DELTA HIP SYSTEM 650-1057Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00880304521957), received between Apr 25, 2019 and Jul 14, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED BY LEGAL THAT A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. THE PATIENT HAD BEEN DOING WELL FOR 6 YEARS BUT PRESENTED WITH SUDDEN SQUEAKING IN THE HIP AFTER AN ACTIVE DAY. X-RAY AND CT SHOWED EVIDENCE OF A DISSOCIATED POLY INSERT. THE PATIENT RETURNED TO SURGERY 6 YEARS AND 2 MONTHS POST THE INITIAL OPERATION. DURING WHICH, A PSEUDOCAPSULE WAS DEBRIDED FROM THE JOINT WHICH REVEALED A DISLODGED POLY LINER AND A DARK STRIPE WEAR ON THE CERAMIC HEAD. THE HEAD WAS REMOVED FROM THE TAPER SLEEVE, BUT THE SLEEVE WAS COLD WELDED TO THE FEMORAL COMPONENT AND COULD NOT BE REMOVED. WHEN THE LINER WAS REMOVED FROM THE CUP, IT WAS IDENTIFIED THAT THE POLY LOCKING RING HAD SHEARED OFF THE POLY AND WAS STILL PRESENT IN THE LOCKING GROOVE OF THE ACETABULAR COMPONENT. THE INITIAL STEM AND CUP REMAINED INTACT. NO INTRA-OP COMPLICATIONS WERE IDENTIFIED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Metal Related Pathology

  MAUDE report 22493228 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SIX YEARS AGO THE PATIENT UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY. FOUR YEARS LATER THE PATIENT PRESENTED FOR AN OFFICE VISIT DUE TO SEVERE RIGHT INGUINAL PAIN. THE PATIENT REPORTED SHE HAD STARTED PILATES AND NEW EXERCISES. X-RAYS SHOWED THE IMPLANTS WERE IN SATISFACTORY POSITION WITHOUT COMPLICATIONS. THE PATIENT WAS DIAGNOSED WITH HIP FLEXOR TENDONITIS, INSTRUCTED TO LIMIT EXERCISES FOR TWO WEEKS, AND WAS PRESCRIBED AN ORAL STEROID DOSE PACK. THE PATIENT DID WELL UNTIL A YEAR AGO, WHEN REPORTED TO THE CARE TEAM OF WORSENING GROIN PAIN ALONG WITH DIFFICULTY RAISING LEG. THE PATIENT WAS GIVEN AN ULTRASOUND AND FLUOROSCOPICALLY GUIDED RIGHT PSOAS BURSA INJECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Inflammation; Pain

  MAUDE report 21444318 ↗
• InjuryJan 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 18482206 ↗
• InjuryJan 10, 2024Adverse 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: Inflammation; Loss of Range of Motion; Pain

  MAUDE report 18481991 ↗
• InjuryJan 9, 2024Adverse 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: Ambulation or Postural Difficulties; Pain

  MAUDE report 18474588 ↗
• 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 18289780 ↗
• 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 11869259 ↗
• InjurySep 23, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS PLANNED TO UNDERGO REVISION SURGERY DUE TO LEG LENGTH DISCREPANCY.

  Patient problems: No Code Available

  MAUDE report 9103716 ↗
• 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 8673873 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FEMORAL HEAD AND ACETABULAR LINER EXCHANGE 6 WEEKS POST INITIAL TOTAL HIP ARTHROPLASTY DUE TO A SUPERFICIAL SEROMA INFECTION.

  Patient problems: Bacterial Infection; Cellulitis; Pain; Seroma; Swelling/ Edema; Unspecified Infection

  MAUDE report 8548659 ↗

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