Biolox® delta 00-8775-028-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00889024430280), received between Feb 12, 2019 and Jul 8, 2026 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Fracture

  IT WAS REPORTED THAT THE 28 MM CERAMIC INNER HEAD BROKE WHEN THE DM HEAD WAS FORCED INTO THE STEM. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A DIFFERENT BEARING AND HEAD. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25748638 ↗
• InjuryAug 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION 7 MONTHS POST IMPLANTATION DUE TO A FALL WHEN GOING DOWN THE STAIRS. THE SURGEON NOTED THAT THE DUAL MOBILITY WAS THEN DISASSEMBLED. REOPERATION WAS COMPLETED BY REPLACING THE HEAD AND BEARINGS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 22700130 ↗
• InjurySep 4, 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: Bone Fracture(s); Pain

  MAUDE report 17676042 ↗
• InjuryFeb 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 16402948 ↗
• InjuryJan 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY, AND APPROXIMATELY 2 YEARS LATER MEDICAL INTERVENTION WAS REQUIRED DUE TO DISLOCATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 16263286 ↗
• InjuryJan 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY, AND APPROXIMATELY 9 YEARS LATER MEDICAL INTERVENTION WAS REQUIRED DUE TO DISLOCATION. THE PATIENT WAS ADMITTED OVERNIGHT FOR PAIN RELIEF. THE PATIENT DID NOT UNDERGO A REVISION, THE IMPLANTS ARE STILL IN PLACE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 16263202 ↗
• InjurySep 2, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn; Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn

  INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: Failure of Implant; Necrosis; Pain

  MAUDE report 12412686 ↗
• InjuryAug 26, 2021Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  BASED ON THE PROVIDED INFORMATION, THE ISSUE OCCURRED WHEN THE LINER DISLOCATED FROM THE SHELL, BOTH OF WHICH ARE PRODUCTS COVERED IN THE SPLIT CASE ZIMMER INC., WARSAW (B)(4), MFR 0001825034-2021-02412 AND 0001825034-2021-02413). THE BLOOD LOSS AND DELAY OF SURGERY WERE THEN DUE TO THE DISLOCATION. THERE DOES NOT SEEM TO BE ANY ISSUE WITH THE BIOLOX HEAD. THIS CASE WILL BE INVALIDATED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12370326 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS IMPLANTED ON THE LEFT SIDE AND POST THE IMPLANTATION SURGERY, THE PATIENT EXPERIENCED DELAYED WOUND HEALING. A FINE NEEDLE ASPIRATION OF THE JOINT WAS PERFORMED.

  Patient problems: Impaired Healing

  MAUDE report 12353501 ↗
• InjuryMay 4, 2021Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT WAS IMPLANTED ON THE LEFT SIDE AND UNDERWENT REVISION A SURGERY DUE TO DEEP INFECTION AND SEPSIS.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 11769726 ↗
• InjuryOct 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO RECURRENT DISLOCATIONS.

  Patient problems: No Code Available

  MAUDE report 10634674 ↗
• InjurySep 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 10598831 ↗
• InjuryFeb 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: No Information

  MAUDE report 9701601 ↗
• InjuryJan 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 9557613 ↗
• InjuryNov 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PLEASE REFER TO REPORT 0009613350-2019-00693.

  Patient problems: Pain

  MAUDE report 9381145 ↗
• InjuryMay 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 8595322 ↗
• InjuryMar 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLEASE REFER TO REPORT 0009613350-2019-00179.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8467986 ↗
• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INVESTIGATION RESULTS HAVE BEEN MADE AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Tissue Damage

  MAUDE report 8330854 ↗