Biolox® delta 00-8775-036-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00889024430372), received between Nov 7, 2018 and Apr 23, 2026 — classified as 28 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Noise, Audible

  IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO REPORTED NOISES AND PREMATURE POLY WEAR. THE PATIENT REPORTED SQUEAKING DURING WALKING AND MOBILIZATION WITHOUT PAINFUL SYMPTOMS, WHICH LIMITED DAILY ACTIVITIES. THE REVISION WAS PERFORMED AND THERE WAS PREMATURE WEAR OF THE POLYETHYLENE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 24964602 ↗
• InjuryOct 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, APPROXIMATELY 4 MONTHS AND A HALF POST IMPLANTATION UNDERWENT A REVISION SURGERY ON NEUTRAL G7 LINER AND 12/14 36MM CERAMIC FEMORAL HEAD DUE TO REPEATED DISLOCATIONS. SURGEON STATED IMPLANT POSITION LOOKED GOOD ON CT. NO CLEAR PATTERN TO DISLOCATIONS. ON TABLE SURGEON STATED HIP FELT VERY STABLE. LIKELY DISLOCATING DUE TO LARGE AMOUNT OF SCAR TISSUE AROUND CUP, POSSIBLE LEVERING OFF THIS OR PATIENT'S LARGE BODY HABITUS. REVISED TO DUAL MOBILITY WITH A +7 FEMORAL HEAD FOR ADDED STABILITY. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 23350451 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION.

  Patient problems: Bursitis; Pain

  MAUDE report 22850507 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT HIP REVISION POST IMPLANTATION DUE TO UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21731459 ↗
• InjuryFeb 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO DISLOCATION. 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 21421598 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT ALLEGES PAIN IN HIP AND SEVERE ANAPHYLAXIS. IT IS UNKNOWN IF REVISION SURGERY IS PLANNED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 21375113 ↗
• InjuryOct 30, 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

  MAUDE report 20568423 ↗
• InjuryAug 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY DUE TO DISLOCATION, APPROXIMATELY SIX YEARS AFTER IMPLANTATION. THE LINER AND HEAD WERE REVISED. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Joint Dislocation

  MAUDE report 20085526 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Pain; Rash; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 18266145 ↗
• InjuryDec 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 18264967 ↗
• MalfunctionJul 18, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED A HAIR WAS FOUND IN THE STERILE PACKAGING. NO CONSEQUENCES OR IMPACT TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15037454 ↗
• InjuryJun 3, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bacterial Infection

  MAUDE report 14586715 ↗
• InjuryMar 24, 2022Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 13888569 ↗
• InjuryDec 7, 2021Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNCOMPLICATED REVISION OF THE HEAD AND STEM. THE INITIAL SHELL AND LINER WERE RETAINED. PATIENT INVOLVEMENT- REVISION SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 12952397 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY AND EXPERIENCED POSTOP PNEUMONITIS REQUIRING ADDITIONAL INTERVENTION AND PROLONGED HOSPITALIZATION. THE COMPLICATION RESOLVED BY POSTOP DAY 2. UPON FOLLOW UP, THE PATIENT HAD MINIMAL PAIN AND PROBLEMS.

  Patient problems: Pain; Pneumonia

  MAUDE report 12546466 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Hematoma

  MAUDE report 12384446 ↗
• InjuryAug 13, 2021Insufficient Device Problem Information

  NOTE: IN ONE OF THE FOLLOW-UP RESPONSES IN THE COMPLAINT, IT WAS STATED THAT THE LEFT HIP CAUSED THE PAIN AND LIMPING, NOT THE RIGHT HIP (WHICH IS WHERE ZB DEVICES ARE IMPLANTED). BECAUSE OF THIS, IT IS NOW CLEAR THAT THE COMPLAINED PRODUCTS ARE NOT ZIMMER BIOMET PRODUCTS. THEREFORE, PLEASE DELETE THIS REPORT FROM YOUR SYSTEM: (B)(4) / MFR: 0009613350-2021-00404-1.

  Patient problems: Pain

  MAUDE report 12317962 ↗
• MalfunctionAug 9, 2021Crack

  DURING AN INITIAL SURGERY, THE FEMUR FRACTURED WHILE IMPLANTING THE DEVICE. THERE WAS A PERIPROSTHETIC CALCAR CRACK, WHICH WAS TREATED WITH A FEMUR CABLE. THE PATIENT HAS NO COMPLAINTS POST THE INITIAL SURGERY. THE PATIENT INVOLVED IN THE EVENT WAS A PART OF THE FOLLOWING STUDY: PROSPECTIVE MULTICENTER LONGITUDINAL COHORT STUDY INCLUDING AN INTERVENTIONAL (SOC) RCT SUB-STUDY.

  Patient problems: Bone Fracture(s)

  MAUDE report 12294066 ↗
• InjuryMay 31, 2021Adverse Event Without Identified Device or Use Problem

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 11906981 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10768659 ↗
• InjuryApr 15, 2020Fracture; Mechanical Problem; Insufficient Device Problem Information; Fracture; Mechanical Problem; Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED ON RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO PAIN CAUSED BY IMPLANT FRACTURE, METALLOSIS, AND WEAR. DURING THE REVISION, THE SURGEON DEBRIDED METALLOSIS, REMOVED PSEUDOTUMOR, NOTED ACETABULUM BONE LOSS, IMPLANT WEAR, AND LINER FRACTURE. DUE TO METAL DEBRIS NOTED AT TRUNNION AND TRUNNION ADAPTER, COMPONENTS WERE UNABLE TO DISENGAGE AND ELECTED TO REMOVE THE STEM. ALL COMPONENTS WERE REVISED, AND A PLATE AND CABLE SYSTEM WAS USED FOR FRACTURE STABILIZATION. AFTER THE SECOND REVISION, THE PATIENT CONTINUED TO EXPERIENCE COMPLICATIONS FROM THE ELEVATED TITANIUM LEVELS INCLUDING HEADACHES, FATIGUE, AND OCULAR SWELLING WITH VISUAL DISTURBANCES.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Metal Related Pathology; No Information; Osteopenia/ Osteoporosis; Pain

  MAUDE report 9961646 ↗
• InjuryMar 16, 2020Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  PLEASE REFER TO REPORT 0009613350-2020-00121.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 9835416 ↗
• InjuryNov 28, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 9390173 ↗
• InjuryNov 19, 2019Packaging Problem; Packaging Problem

  PLEASE REFER TO REPORT 0009613350-2019-00684.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9339819 ↗
• InjuryDec 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PLEASE REFER TOREPORT 0009613350-2018-01229.

  Patient problems: Joint Dislocation

  MAUDE report 8159529 ↗