Biolox® delta 00-8775-028-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00889024430303), received between Jul 3, 2019 and Oct 18, 2024 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 20482956 ↗
• MalfunctionSep 30, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING SURGERY THAT THE CERAMIC HEAD WOULD NOT ARTICULATE PROPERLY WITH THE BIPOLAR LINER. AN ATTEMPT TO GET THE BALL FURTHER IN CASE IT WAS NOT FULLY IN THE LINER, WOULD STILL NOT ARTICULATE PROPERLY. DEVICES WERE NOT IMPLANTED INTO THE PATIENT AND THERE WAS NO REPORTED PATIENT IMPACT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333120 ↗
• MalfunctionSep 11, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT IN A HIP PROCEDURE, AFTER COMPRESSING THE HEAD INTO THE BEARING THE HEAD DEMONSTRATED "SHUCK" IN THE BEARING. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192438 ↗
• MalfunctionJul 18, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED IN AN INITIAL PROCEDURE THAT WHEN THE SURGEON PLACED THE CERAMIC HEAD OVER THE MULLER STEEL TAPER, IT IMMEDIATELY GOT SKEWED UNDER A STRANGE ANGLE. IT DID CLAMP A BIT, SO IMPACT WAS ATTEMPTED TWICE WITHOUT SUCCESS. IT WAS THEN NOTICED THAT FLAKES WERE COMING OFF THE HEAD. SURGERY WAS COMPLETED WITH ANOTHER DEVICE WITHOUT IMPACT OR CONSEQUENCE TO THE PATIENT. UPON RECEIPT OF THE CERAMIC HEAD FOR EVALUATION, IT WAS FOUND TO BE FRACTURED. NO PATIENT HARM OR FURTHER CONSEQUENCE WAS REPORTED, HOWEVER THIS EVENT HAS LED TO SERIOUS INJURY IN THE PAST. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19776946 ↗
• InjuryMar 27, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT HIP REVISION POST-IMPLANTATION DUE TO A DISLOCATION DURING A DEEP SQUAT; THE HEAD AND LINER WERE EXCHANGED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 18985556 ↗
• InjuryFeb 13, 2024Mechanical Problem; Mechanical Problem

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

  Patient problems: Insufficient Information

  MAUDE report 18696951 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Joint Impingement; Pain

  MAUDE report 17938175 ↗
• InjuryJun 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CERAMIC HEAD DISASSOCIATED FROM THE STEM WHILE THE PATIENT WAS IN THE POST-ANESTHESIA CARE UNIT AND HAD TO BE BROUGHT BACK TO SURGERY TO EXCHANGE THE HEAD. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 14560637 ↗
• InjuryMar 4, 2022Unstable; Use of Device Problem; Unstable; Use of Device Problem

  IT WAS REPORTED THAT, DURING A REVISION SURGERY OF HIP REPLACEMENT, THE SURGEON ENCOUNTERED DIFFICULTIES WITH THE INSTALLATION OF THE JOINT BETWEEN THE HEAD AND THE LINER. INDEED, THE TWO ITEMS SLIDE APART VERY EASILY. THE SURGEON ELECTED TO IMMEDIATELY REVISE THE LINER AND HEAD. THESE ITEMS WERE EXPLANTED. THE SURGERY TOOK AROUND 25 MINUTES LONGER THAN EXPECTED DUE TO THE NEED TO REVISE THE IMPLANTED HEAD AND LINER.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 13665525 ↗
• MalfunctionFeb 3, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE HEAD WAS STUCK HARD IN THE LINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13441610 ↗
• InjuryJun 4, 2020Appropriate Device Problem Term/Code Not Available; Noise, Audible

  PATIENT WAS IMPLANTED ON RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO PAIN, LIMITED RANGE OF MOTION, GRINDING SOUND.

  Patient problems: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 10117947 ↗
• InjuryFeb 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION DUE TO DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9675237 ↗
• InjuryJul 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PLEASE REFER TO REPORT 0009613350-2019-00414.

  Patient problems: No Code Available

  MAUDE report 8757068 ↗