Biolox® delta 00-8775-032-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024430310), received between Dec 12, 2018 and Apr 1, 2025 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL HIP REPLACEMENT AND SUBSEQUENTLY, APPROXIMATELY THREE YEARS POST-OP REPORTED MODERATE PAIN AND WAS DIAGNOSED WITH RIGHT TROCHANTERIC BURSITIS AND GIVEN A CORTISONE INJECTION. ALL IMPLANTS REMAIN IN PLACE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bursitis; Pain

  MAUDE report 21740255 ↗
• InjuryDec 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: Bursitis; Pain

  MAUDE report 20891232 ↗
• InjuryMay 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE. SUBSEQUENTLY, APPROXIMATELY 7 MONTHS POST-IMPLANTATION, THE PATIENT WAS REVISED DUE TO MALALIGNMENT - SOCKET DISLOCATION/SUBLUXATION. ACETABULAR CUP, MODULAR HEAD, ACETABULAR LINER WERE REVISED. DILIGENCE IS COMPLETED AND NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS NEEDED AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 19353502 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TOTAL HIP REPLACEMENT WAS PERFORMED. SUBSEQUENTLY, APPROXIMATELY 3 MONTHS POST IMPLANTATION THE PATIENT UNDERWENT A REVISION SURGERY DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE IT AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19271471 ↗
• MalfunctionOct 5, 2023Device Damaged Prior to Receipt by User; Use of Device Problem; Device Damaged Prior to Receipt by User; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY, AND DURING SURGERY AN INCORRECT HEAD HAD BEEN IMPLANTED. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875325 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO WOUND COMPLICATION, HEMATOMA AND DRAINING SINUS.

  Patient problems: Bacterial Infection; Hematoma; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 16310546 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY APPROXIMATELY THREE (3) YEARS AGO. SUBSEQUENTLY, APPROXIMATELY TWO (2) YEARS AGO, THE PATIENT REPORTED DEVELOPING PAIN IN THE RIGHT HIP. THE PATIENT HAD AN MRI WHERE INFECTIOUS LESIONS AND ABSCESS FORMATION IN THE UPPER FEMUR, HIP AND PERIPROSTHETIC SOFT TISSUE WERE FOUND. PATIENT WAS ADMITTED TO HOSPITAL THE FOLLOWING DAY AND UNDERWENT A RIGHT HIP LESION INCISION AND EXPLORATION, DEBRIDEMENT AND DILATION, INTERNAL FIXATION REMOVAL, DEVICE REVISION AND TUBE FLUSHING AND DRAINAGE. THE HEAD AND LINER WERE REMOVED AND REPLACED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15957424 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SIX MONTH HISTORY OF GROIN-HIP FLEXOR PAIN ON STRAIGHT LEG RAISE AND WALK WAS REPORTED. THE PATIENT DEVELOPED THE SYMPTOMS BETWEEN THE 7 AND 10 YEAR FOLLOW UP. NO FURTHER OUTCOME HAS BEEN REPORTED. THE DEVICES REMAIN IMPLANTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Implant Pain

  MAUDE report 14942299 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SIX MONTH HISTORY OF GROIN-HIP FLEXOR PAIN ON STRAIGHT LEG RAISE AND WALK WAS REPORTED. THE PATIENT DEVELOPED THE SYMPTOMS BETWEEN THE 7 AND 10 YEAR FOLLOW UP. NO FURTHER OUTCOME HAS BEEN REPORTED. THE DEVICES REMAIN IMPLANTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Implant Pain

  MAUDE report 14942295 ↗
• InjuryJun 15, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT STATES TO HAVE HAD PAIN IN THE GROIN AND BOTH LEGS SINCE THE PROCEDURE. THE DOCTOR TOLD THE PATIENT THAT THE IMPLANTS WERE INSTALLED CROOKED. NO REVISION HAS BEEN REPORTED TO DATE. NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 14692523 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS A HIP REVISION DUE TO UNKNOWN REASON. EVENT REPORTED DURING THE PMCF STUDY.

  Patient problems: Failure of Implant

  MAUDE report 13929873 ↗
• InjuryDec 11, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 10990814 ↗
• InjuryOct 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS IMPLANTED ON LEFT SIDE AND UNDERWENT REVISION DUE TO RECURRENT ANTERIOR DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10760672 ↗
• InjuryOct 6, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS IMPLANTED ON THE LEFT SIDE AND HAD TO UNDERGO A WOUND DEBRIDEMENT DUE TO A SUPERFICIAL INFECTION. PATIENT REPORTED SATISFACTION AND NO OTHER COMPLICATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 10634675 ↗
• InjuryDec 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PLEASE REFER TO REPORT 0009613350-2018-01272.

  Patient problems: No Code Available

  MAUDE report 8178236 ↗
• InjuryDec 12, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PLEASE REFER TO REPORT 0009613350-2018-01222.

  Patient problems: Joint Dislocation

  MAUDE report 8154791 ↗
• InjuryDec 12, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PLEASE REFER TO REPORT 0009613350-2018-01219.

  Patient problems: Joint Dislocation

  MAUDE report 8154661 ↗