BIOLOX DELTA 1365-36-230Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10603295033585), received between Jul 7, 2017 and Sep 30, 2026 — classified as 46 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (24 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 48 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Dislodged or Dislocated

  It was reported that the patient was revised to constrained liner due to dislocation. DOI: Unknown .DOR: (b)(6)2026.Affected side: Left hip.

  Patient problems: Joint Dislocation

  MAUDE report 50947516 ↗
• InjurySep 23, 2026Device Dislodged or Dislocated

  It was reported that reoccurring dislocation of competitor's cup was removed Sleeve was stable new stem and head were implanted.Affected side: Right Hip.

  Patient problems: Joint Dislocation

  MAUDE report 50868167 ↗
• InjuryJan 2, 2026Device Dislodged or Dislocated

  PATENT REVISED DUE TO DISLOCATION. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT.

  Patient problems: Joint Dislocation

  MAUDE report 23944035 ↗
• InjuryJan 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION OF TOTAL HIP. SURGEON REMOVED THE HEAD AND LINER AND REPLACED WITH DIFFERENT CONSTRUCT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21256419 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE HIP. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 20268956 ↗
• InjuryApr 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION OF TOTAL HIP ARTHROPLASTY. SURGEON PULLED THE STEM, HEAD, AND LINER, THEN CHANGED THE VERSION IN THE FEMORAL STEM. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19127669 ↗
• InjuryJan 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED CHRONIC DISLOCATION. LIPPED LINER AND LONGER HEAD BALL WAS USED. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6), 2016. DOR: (B)(6), 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18517396 ↗
• InjuryOct 25, 2023Fracture; Fracture

  FRACTURED SROM CERAMIC HEAD (11/13) 36+6. HEAD AND LINER CHANGED TO PINNACLE LINER (LIKE FOR LIKE) AND A BIOBALL CERAMIC HEAD WITH 11/13 SLEEVE.

  Patient problems: Insufficient Information

  MAUDE report 18005686 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ADVERSE REACTION TO METAL DEBRIS FROM HIS CERAMIC ON METAL HIP. THE METAL LINER AND CERAMIC HEAD WERE EXPLANTED AND REPLACED WITH A POLY LINER AND METAL HEAD. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 16885424 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PATIENT EXPERIENCING PAIN AND DISCOMFORT. UPON FURTHER INVESTIGATION IT WAS DISCOVERED PATIENT HAD ELEVATED CHROMIUM LEVELS. METAL LINER WAS REVISED TO A POLY. HEAD WAS REVISED TO A CERAMIC HEAD. DOI: (B)(6), DOR: (B)(6), AFFECTED SIDE: LEFT HIP.

  Patient problems: Discomfort; Metal Related Pathology; Pain

  MAUDE report 16776631 ↗
• MalfunctionMar 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR INITIAL DISLOCATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2023. (RIGHT HIP). TREATMENT: KNEE IMMOBILIZER.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 16477146 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED EXCEPT THE PROXIMAL SLEEVE. NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AND AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16405830 ↗
• InjuryJan 24, 2023Fracture; Fracture

  PATIENT REVISED DUE TO CERAMIC ON CERAMIC HAD A CATASTROPHIC FAILURE AFTER THE PATIENT WAS RUNNING WIND SPRINTS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16232949 ↗
• InjuryDec 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED DUE TO LEG LENGTH DISCREPANCY FROM A DYSPLASTIC HIP. SURGEON REMOVED STEM AND FEMORAL HEAD AND THEN REMOVED A 3CM SECTION OF THE FEMUR. CANAL WAS REAMED WITH FLEXIBLE REAMERS. HE THEN TRIALED A 11X16 36 STD +6 STEM AND A 36 +9 FEMORAL HEAD. THOSE SIZES WERE THEN IMPLANTED. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 16033242 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2022. LEFT HIP. TREATMENT: REMOVAL OF ALL COMPONENTS. WERE DEPUY COMPONENTS REMOVED: YES.

  Patient problems: Unspecified Infection

  MAUDE report 15033925 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTED HIP AND LOOSENING OF CUP AT BONE TO IMPLANT INTERFACE. NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14113600 ↗
• InjuryFeb 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND A REMOTE POSSIBILITY RELATION TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6) 2022, (LEFT HIP). TREATMENT: MANIPULATION UNDER ANESTHESIA.

  Patient problems: Joint Dislocation

  MAUDE report 13558914 ↗
• InjurySep 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED HIS HIP. SURGEON REPLACED STEM, LINER, AND HEAD. DOI: (B)(6) 2021. DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12555253 ↗
• InjurySep 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT HAD COMPLAINTS OF RIGHT HIP INCISION BLEEDING. DURING ER ENCOUNTER IT WAS REPORTED THAT WOUND HAD A SMALL AMOUNT OF RED DRAINAGE COMING FROM THE PROXIMAL ASPECT AND A SMALL 1 CM AREA OF DEHISCENCE. IT WAS ALSO REPORTED THAT PATIENT HAD CLOSED REDUCTION DUE TO DISLOCATION. CLINIC VISITS REPORTED OF WEAKNESS, PAIN, FEELING OF SNAPPING OR POPPING, DISCOMFORT AND STIFFNESS, DOI: (B)(6) 2020. DOR: NONE REPORTED. RIGHT HIP.

  Patient problems: Discomfort; Fatigue; Fluid Discharge; Joint Dislocation; Muscular Rigidity; Pain; Wound Dehiscence

  MAUDE report 12487692 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORT: IT WAS REPORTED THAT PATIENT HAD AN INFECTED TOTAL HIP. WASHED OUT AND EXCHANGED CONSTRAINED LINER THAT WAS SWAP OUT ON (B)(6) 2021. ALSO EXCHANGED SROM FEMORAL HEAD THAT WAS IMPLANTED (B)(6) 2017 AT (B)(6). DOI: (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 12473646 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: IT WAS REPORTED THAT THE PATIENT CAME BACK IN WITH A CANDIDA FUNGAL INFECTION. DR. (B)(6) DECIDED IT BEST TO REMOVE ALL IMPLANTS AND PLACE AN ANTIBIOTIC SPACER IN TO HELP THE INFECTION CLEAR. THE SLEEVE AND CUP WERE IMPLANTED AT AN EARLIER TIME AND THE NUMBERS WERE UNREADABLE. THE STEM, LINER, AND HEAD WERE REVISED ON (B)(6) 2020, AND INFORMATION WAS OBTAINED FROM THAT PAPERWORK. THE CUP WAS A 56 PINNACLE AND THE STEM SLEEVE WAS AN 18. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12440508 ↗
• InjurySep 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2013, THE PATIENT UNDERWENT A PRIMARY RIGHT HIP ARTHROPLASTY WITH NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2020, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOLLOWING A FALL AFTER TRIPPING OVER A DOG AND TWISTING THE HIP. THE RIGHT HIP BECAME DISLOCATED AND THE PATIENT UNDERWENT A CLOSED REDUCTION IN THE EMERGENCY DEPARTMENT. IT WAS INDICATED THAT THE PATIENT WAS EXPERIENCING PAIN DUE TO THE DISLOCATION. THERE IS NO EVIDENCE OF REVISION.

  Patient problems: Fall; Joint Dislocation; No Code Available; Pain

  MAUDE report 10489852 ↗
• InjuryFeb 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF, IMPLANT RECORDS AND STICKER SHEETS. PPF ALLEGED DISLOCATION (CLOSED REDUCTION) AFTER FIRST REVISION. DOI: (B)(6) 2018 DOR: NONE REPORTED LEFTHIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9723023 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IRRIGATION AND DEBRIDEMENT DUE TO INFECTION WITH HEAD AND POLY EXCHANGE. DOI: (B)(6) 2019; DOR: (B)(6) 2020; (RIGHT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9633021 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PSEUDOTUMOR AND ABDUCTOR MUSCLE REPAIR AFTER 1ST REVISION. DOI: (B)(6) 2004, (CUP, SCREWS). DOR: (B)(6) 2017, (HEAD, LINER), (LEFT HIP).

  Patient problems: Hypersensitivity/Allergic reaction; Tissue Damage

  MAUDE report 9539713 ↗