BIOLOX® delta Modular Ceramic Head 650-0660Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00887868271168), received between Jul 2, 2021 and Mar 20, 2026 — classified as 13 injuries, 2 malfunctions.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO LEG LENGTH DISCREPANCY. THE LEG OF THE PATIENT WAS CONSIDERABLY LONGER, APPROXIMATELY TWENTY MM, SO THE SURGEON DECIDED TO REMOVE THE PROXIMAL BODY OF THE STEM AND REDUCE THE LEG LENGTH DISCREPANCY BY TEN MM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unequal Limb Length

  MAUDE report 24648269 ↗
• InjurySep 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION.

  Patient problems: Joint Dislocation

  MAUDE report 23061212 ↗
• InjuryMar 10, 2025Adverse 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: Subluxation

  MAUDE report 21557911 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR AND FIVE MONTHS LATER DUE TO LEG LENGTH DISCREPANCY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unequal Limb Length

  MAUDE report 20123584 ↗
• InjuryAug 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY. THE SAME DAY, THE PATIENT HIP DISLOCATED, AND THE SURGEON DECIDED TO REVISE THE PATIENT THE SAME DAY. THE HEAD, LINER, AND STEM WERE EXCHANGED. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 20075284 ↗
• InjuryAug 23, 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: Pain; Unspecified Infection

  MAUDE report 20046634 ↗
• InjuryJun 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS AND TWO WEEKS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION DUE TO HIP DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 19556432 ↗
• InjuryMar 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION ON THE SAME DAY AS THE INITIAL IMPLANT DUE TO A POST-OP DISLOCATION. THE LINER AND HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 18928335 ↗
• MalfunctionDec 4, 2023Degraded; Degraded

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18254363 ↗
• InjuryOct 9, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

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

  Patient problems: Pain

  MAUDE report 17894220 ↗
• InjuryAug 29, 2023Adverse 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 2 YEARS AND 27 DAYS POST IMPLANTATION DUE TO INFECTION. IT WAS NOTED THAT THE CUP WAS NOT WELL FIXED. A WASHOUT WAS PERFORMED WITH AN EXCHANGE OF THE HEAD AND LINER. FIVE SCREWS WERE ALSO EXPLANTED. SURGEON DECIDED ALL METALWARE NEEDED TO BE REMOVED AND A GIRDLE STONES HIP WAS TO REMAIN FOR FUTURE ASSESSMENT AND MANAGEMENT OF THE INFECTION. A WELL FIXED ARCOS STS/CONE WAS REMOVED VIA ETO. TISSUE SAMPLES TAKEN AND WOUND CLOSED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 17643117 ↗
• InjuryNov 2, 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 SURGERY OF THE HIP DUE TO INFECTION, APPROXIMATELY TWO (2) MONTHS POST-OP. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 15713500 ↗
• 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 LEFT HIP APPROXIMATELY THREE (3) DAYS POST IMPLANTATION DUE TO PERIPROSTHETIC FRACTURE AFTER A FALL TWO (2) DAYS POST IMPLANTATION. THE FRACTURE WAS SECURED WITH A PLATE AND CABLES, AND THE FEMORAL HEAD AND STEM WERE REPLACED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THISTIME.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 14641410 ↗
• InjuryOct 2, 2021Material Erosion; Material Erosion

  IT WAS REPORTED THAT PATIENT IS EXPERIENCING PAIN, LOSS OF BALANCE, DIZZINESS, DIFFICULTY WALKING AND UPSET STOMACH. PATIENT ALSO ALLEGES ELEVATED SERUM CHROMIUM AND COBALT LEVELS, METALLOSIS, TISSUE DEHISCENCE, TISSUE NECROSIS, BONE NECROSIS, HYPERTROPHIC SCARRING, ANTALGIA, LUMBAR STRAIN, CHRONIC FATIGUE AND SEVERE DISTRESS RELATED TO PAIN AND SUFFERING AFTER AN UNKNOWN AMOUNT OF TIME POST TOTAL HIP ARTHROPLASTY. NO REVISION SURGERY HAS BEEN REPORTED TO DATE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Dizziness; Fatigue; Necrosis; Pain

  MAUDE report 12566347 ↗
• MalfunctionJul 2, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHEN THE BOX WAS OPENED, THE STICKERS INSIDE DID NOT MATCH THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105838 ↗