BIOLOX® delta Option 650-1055Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00887868271373), received between Dec 17, 2020 and Aug 10, 2026 — classified as 35 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (18 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Fracture

  It was reported that the ceramic head fractured upon impact during the procedure. The surgeon completed the surgery using an alternative device. The fractured ceramic head did not come into contact with the patient, and no fragments remained in the patient. There was no serious injury to the patient and no delay in the procedure. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50190710 ↗
• InjuryJun 1, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR AND FOUR MONTHS AGO, THE PATIENT UNDERWENT A LEFT HIP REVISION SURGERY DUE TO JOINT DISLOCATION. SINCE THAT PROCEDURE, THE PATIENT HAS EXPERIENCED RECURRENT LEFT HIP DISLOCATIONS. THE PATIENT IS NOW BEING CONSIDERED FOR A NEW PMI CUSTOM CONSTRAINED LINER TO ADDRESS THE ONGOING INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 25347010 ↗
• InjuryFeb 2, 2026Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO UNKNOWN REASONS. HOWEVER, DURING THE REVISION SURGERY, THE CERAMIC FEMORAL HEAD FRACTURED WHILE THE SURGEON WAS ATTEMPTING TO REMOVE THE TAPER SLEEVE FROM THE CERAMIC HEAD BY TAPPING IT WITH A MALLET. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 24233270 ↗
• InjuryJan 12, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY ONE YEAR AND EIGHT MONTHS POST-IMPLANTATION DUE TO DISSOCIATION OF THE FEMORAL HEAD AND BEARING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 24033893 ↗
• InjuryNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Joint Dislocation

  MAUDE report 23579374 ↗
• InjurySep 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: Joint Laxity; Medical device site infection; Periprosthetic fracture

  MAUDE report 23013649 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, POST-IMPLANTATION, THE PATIENT ALLEGED EXPERIENCING MULTIPLE ISSUES, INCLUDING: EXCRUCIATING PAIN IMMEDIATELY AFTER SURGERY; A METALLIC TASTE IN THE MOUTH (WITH A CORRESPONDING NICKEL ALLERGY); A RASH ON THE LEG; SENSATIONS OF FEMORAL SHIFTING; TWO ROUNDS OF ANTIBIOTIC TREATMENT PLUS IV ANTIBIOTICS FOR INFECTION; LIMITED MOBILITY; NUMBNESS IN THE TOES WHEN LYING ON THE SIDE; HEART ATTACK¿LIKE SYMPTOMS; BACK PAIN; POTASSIUM AND MAGNESIUM INFUSIONS FOR AN UNKNOWN REASON, WHICH REPORTEDLY MADE THEM FEEL WORSE; ALLEGED PASSAGE OF A 5 MM PIECE OF METAL IN THE URINE (WHICH THE SURGEON STATED WAS MOST LIKELY A KIDNEY STONE); AND OTHER GREEN PARTICLES IN THE URINE, SUSPECTED TO BE SUTURE MATERIAL. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Hypersensitivity/Allergic reaction; Pain; Rash; Unspecified Infection

  MAUDE report 22837754 ↗
• InjuryJul 11, 2025Device Dislodged or Dislocated; Premature Separation; Device Dislodged or Dislocated; Premature Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION SURGERY DUE TO THE BEARING AND HEAD DISASSOCIATING. THE BEARING WAS THEN FOUND TO BE STUCK IN THE PELVIS AND WAS UNABLE TO BE RETRIEVED AT THE TIME OF THIS REVISION SURGERY, APPROXIMATELY 2 YEARS AND 9 MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE, AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 22478431 ↗
• InjuryJul 8, 2025Device Dislodged or Dislocated; Premature Separation; Device Dislodged or Dislocated; Premature Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE, FOLLOWED BY A REVISION SURGERY APPROXIMATELY FOUR YEARS LATER DUE TO A DISLOCATION. SUBSEQUENTLY, APPROXIMATELY TWO YEARS AND SIX MONTHS AFTER THE REVISION, THE PATIENT EXPERIENCED ANOTHER DISLOCATION THAT REQUIRED SURGICAL INTERVENTION. DURING THE CLOSED REDUCTION, THE BEARING AND HEAD DISASSOCIATED, NECESSITATING A SECOND REVISION SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 22435095 ↗
• InjuryFeb 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Failure of Implant

  MAUDE report 21364053 ↗
• InjuryJun 21, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE MONTH POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO A DISLOCATION FOR UNKNOWN REASONS AND DISASSOCIATION OF THE DUAL MOBILITY WITH INSTABILITY UPON REDUCTION. THE DECISION WAS MADE TO REVISE THE PATIENT TO A CONSTRAINED PRODUCT. THE STEM WAS RETAINED. THE HEAD AND ACETABULAR COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Dislocation

  MAUDE report 19582020 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY NINE YEARS AND SIX MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED FOR LEG LENGTH DISCREPANCY. IT WAS INDICATED THAT THE PATIENT REQUIRED LONGER HEAD LENGTH. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unequal Limb Length

  MAUDE report 19257903 ↗
• InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 19114925 ↗
• InjuryMar 25, 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: Insufficient Information

  MAUDE report 18967135 ↗
• InjuryMar 11, 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: Insufficient Information; Unequal Limb Length

  MAUDE report 18873079 ↗
• InjuryJan 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 18594048 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO AN INFECTION. DURING THE REVISION, A PSEUDO MEMBRANE, METALLIC FRAGMENTS, AND ABNORMAL TISSUE INCLUDING NECROSIS WAS NOTED. ALL THE IMPLANTS WERE REMOVED AND REPLACED WITH SPACERS. APPROXIMATELY FOUR MONTHS LATER, THE SPACERS WERE REMOVED AND REPLACED WITH ZB IMPLANTS WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Failure of Implant; Metal Related Pathology; Necrosis

  MAUDE report 18254617 ↗
• InjurySep 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 17816666 ↗
• InjuryAug 31, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF HIP IMPLANT DUE TO UNKNOWN REASON. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 17661287 ↗
• InjuryAug 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO DUAL MOBILITY IMPLANT DISASSOCIATION WHEN THE BEARING DISASSOCIATED FROM THE HEAD, APPROXIMATELY TWO (2) YEARS, THREE (3) MONTHS FROM INITIAL SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 17457387 ↗
• InjuryApr 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION DUE TO RETEAR OF THE GLUTEUS MEDIUS, DISLOCATION, AND DISASSOCIATION OF THE DUAL MOBILITY COMPONENTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Dislocation; Muscle/Tendon Damage

  MAUDE report 16687538 ↗
• InjuryFeb 27, 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; Fungal Infection

  MAUDE report 16442312 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A INITIAL LEFT HIP REVISION ARTHROPLASTY. APPROXIMATELY, ONE MONTH LATER THE PATIENT UNDERWENT A 1ST STAGE REVISION DUE BACTERIAL INFECTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Bacterial Infection

  MAUDE report 16213064 ↗
• InjuryOct 18, 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 DUE TO A PSEUDOTUMOR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Local Reaction; Pain

  MAUDE report 15624401 ↗
• InjuryAug 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO A DISLOCATION. THE HEAD AND LINER WERE REPLACED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Joint Dislocation

  MAUDE report 15190756 ↗