BIOLOX® delta Modular Ceramic Head 650-0661Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00887868271175), received between Apr 20, 2021 and Aug 28, 2026 — classified as 26 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Malposition of Device; Device Dislodged or Dislocated

  It was reported that the patient underwent an initial hip procedure. The patient was revised approximately three and a half months post-implantation due to dislocation and malposition of the cup. Attempts have been made and no further information has been provided.

  Patient problems: Joint Dislocation

  MAUDE report 50493614 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 24000810 ↗
• InjuryNov 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY ONE-YEAR POST-IMPLANTATION DUE TO HIP DISLOCATION AND INSTABILITY. A CONSTRAINED LINER WAS IMPLANTED TO ADDRESS THE INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 23542334 ↗
• InjuryAug 21, 2025Device 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 APPROXIMATELY THREE MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO INSTABILITY CAUSED BY DISLOCATION. HEAD AND LINER WERE EXCHANGED TO IMPROVE STABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22865922 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL STUDY THAT A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY TWO YEARS AND EIGHT MONTHS AGO. SUBSEQUENTLY, AFTER THE FIRST YEAR, DEVELOPED CONTRALATERAL LEG SHORTENING AND BEGAN EXPERIENCING PAIN, A LIMP, AND PROBLEMS WALKING. SIX MONTHS AGO, THE PATIENT WAS PRESCRIBED PHYSICAL THERAPY, AND THE OUTCOME IS PENDING. NO FOLLOW-UP IS REQUIRED AT THIS POINT IN TIME AS ALL REQUIRED INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 21983561 ↗
• InjuryApr 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY FIVE WEEKS POST IMPLANTATION, THE PATIENT BENT OVER AND FELT A SENSATION IN THE HIP FOLLOWED BY AN AUDIBLE GRINDING SOUND. SUBSEQUENT X-RAYS CONFIRMED A FRACTURED CERAMIC FEMORAL HEAD. A REVISION SURGERY WAS SCHEDULED TO REPLACE THE FRACTURED HEAD AND LINER. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 21908705 ↗
• InjuryApr 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REVISION SURGERY DUE TO FRACTURE OF THE CERAMIC FEMORAL HEAD, APPROXIMATELY 40 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 21899163 ↗
• InjuryNov 26, 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 20785215 ↗
• InjuryOct 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT TOTAL HIP REPLACEMENT. SUBSEQUENTLY, THE PATIENT DISLOCATED, AND A CLOSED REDUCTION WAS UNSUCCESSFUL. THE PATIENT WAS REVISED APPROXIMATELY 6 WEEKS POST-IMPLANTATION DUE TO THE DISLOCATION. DURING THE REVISION THE LINER AND HEAD WERE EXCHANGED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 20517298 ↗
• InjuryJul 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISLOCATION, APPROXIMATELY 4 MONTHS POST-IMPLANTATION. THE PATIENT HAS HAD MULTIPLE DISLOCATIONS. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 19738858 ↗
• InjuryJul 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY SIX DAYS POST IMPLANTATION DUE TO A DISLOCATION. THE HEAD AND LINER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 19699817 ↗
• InjuryJun 21, 2024Malposition of Device; Noise, Audible; Malposition of Device; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY SIX YEARS AND SIX MONTHS LATER DUE TO POOR ALIGNMENT OF THE ACETABULAR COMPONENT. THERE WAS REPRODUCIBLE AUDIBLE SQUEAKING AND CREPITUS BY THE PATIENT. IT WAS INDICATED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19581875 ↗
• InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE YEAR AND NINE MONTHS POST IMPLANTATION DUE TO PAIN AND DISCOMFORT RELATED TO INCREASED LEG LENGTH, AND OFFSET FROM PRIMARY HIP SURGERY. THE FEMORAL STEM AND HEAD WERE EXCHANGED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Discomfort; Pain; Unequal Limb Length

  MAUDE report 19402953 ↗
• InjuryApr 19, 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; Swelling/ Edema

  MAUDE report 19141719 ↗
• InjuryDec 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISLOCATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Joint Dislocation

  MAUDE report 18309579 ↗
• MalfunctionMay 31, 2023Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 17029088 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS DIAGNOSED WITH POST-OPERATIVE LEFT POPLITEAL, DEEP VEIN THROMBOSIS DESPITE FRAGMIN PRESCRIPTION. SYMPTOMS OF CALF TENSION AND MINIMAL REDNESS BEGAN THREE DAYS AFTER LEFT TOTAL HIP ARTHROPLASTY. THE THROMBOSIS WAS RESOLVED WITHOUT COMPLICATIONS; ALL IMPLANTS REMAINED IN PLACE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Thromboembolism

  MAUDE report 15444509 ↗
• InjuryAug 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY 9 MONTHS POST IMPLANTATION DUE TO FEMORAL HEAD IMPLANT FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15158811 ↗
• InjuryJul 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISLOCATION DUE TO IMPROPER MOTION APPROXIMATELY 1 WEEK POST IMPLANTATION. THE PATIENT'S HIP WAS REDUCED AT ED WITHOUT INCIDENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 15025472 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE RIGHT HIP APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO SUBSIDENCE OF THE FEMORAL STEM AFTER LIMB LENGTH DISCREPANCY WAS NOTED. DURING REVISION, A CRACK IN THE UPPER FEMORAL SHAFT AND THE GREATER TROCHANTER DEVELOPED. THESE WERE REPAIRED AND THE FINAL COMPONENTS WERE REPLACED WITHOUT FURTHER COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s); Osteopenia/ Osteoporosis; Unequal Limb Length

  MAUDE report 14641533 ↗
• InjuryMay 9, 2022Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED, THAT: THE PATIENT UNDERWENT A PRIMARY THA ON THE RIGHT SIDE ON (B)(6) 2022. THE PATIENT HAD HIP PAIN AND WAS ADMITTED TO (B)(6) HOSPITAL. IT WAS SEEN ON THE X-RAY OF THE RIGHT HIP, THAT THE CERAMIC HEAD WAS IN MULTIPLE PIECES AND REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 14333997 ↗
• InjuryApr 19, 2022Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED, THAT: THE PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2022. SUBSEQUENTLY, ON (B)(6) 2022, THE PATIENT LEANED OVER AND DISLOCATED THE RIGHT HIP. A CLOSED REDUCTION WAS PERFORMED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 14140320 ↗
• MalfunctionMar 15, 2022Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED, THAT THE CERAMIC HEAD BROKE AFTER A SINGLE IMPACTION OF THE MALLET ON THE FEMORAL TRUNION.

  Patient problems: Insufficient Information

  MAUDE report 13768433 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: OCCASIONAL PAIN ON THE TOP OF THE RIGHT HIP - SHARP PAIN. TROCHANTERIC REGION. NO FURTHER PATIENT OUTCOME.

  Patient problems: Pain

  MAUDE report 12915734 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY (B)(6) 2021. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE (B)(6) 2021 DUE TO DISLOCATION/INSTABILITY. THE LINER AND HEAD WERE REMOVED AND REPLACED WITH DUEL MOBILITY.

  Patient problems: Joint Dislocation

  MAUDE report 12622856 ↗