BIOLOX DELTA 1365-36-730Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 10603295033677), received between Aug 11, 2017 and Aug 4, 2026 — classified as 1 death, 138 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (65 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 140 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to COP unstable, changing head and liner.DOI: On (b)(6) 2020.DOR: On (b)(6) 2026.Affected side: Left.

  Patient problems: Joint Laxity

  MAUDE report 50128728 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE-RIGHT HIP.

  Patient problems: Pain

  MAUDE report 25085696 ↗
• InjuryFeb 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT COMES BACK IN TODAY FOR A HEAD AND LINER REVISION DUE TO CHRONIC DISLOCATION. THE SURGEON REMOVED THE LINER AND HEAD THEN PLACED A CONSTRAINED LINER WITH A 32 DELTA TS HEAD. NO MORE PATIENT INFORMATION WAS AVAILABLE AT THIS TIME. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24245161 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 24212120 ↗
• InjuryJan 8, 2026Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 24006432 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH HEAD AND CONSTRAINED LINER SWAP DUE TO INCREASING GROIN PAIN IN THE PATIENT. THERE WAS NO INDICATION BY THE SURGEON THAT THE IMPLANTS WERE MECHANICALLY FAILING. UPON EXTRACTION OF THE IMPLANTS IT WAS CONFIRMED THAT THEY WERE IN PLACE AS MECHANICALLY DESIGNED. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 24005631 ↗
• InjuryDec 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A REVISION DUE TO INSTABILITY/DISLOCATION. NO OTHER INFORMATION IS KNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 23837918 ↗
• InjuryDec 2, 2025Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED LEGAL RECORDS WERE RECEIVED. THERE IS GAS AND SOFT TISSUE SWELLING SURROUNDING THE LEFT PROXIMAL FEMUR COMPATIBLE WITH POSTOPERATIVE CHANGES. LOOSENING OF FEMORAL COMPONENT OF PROSTHETIC LEFT HIP, SYNOVIAL FLUID FROM HIP JOINT, LEFT ARTHRITISM, PROGRESSIVE HIP PAIN AND DISABILITY. 10 ML OF BLACK STAINED FLUID, ACUTE METAL WEAR PROCESS, POLYETHYLENE LINER WAS WORN THROUGH SUPERIORLY AND BROKEN IN THE SUPERIOR RIM. THE CERAMIC BALL WAS NOTED TO HAVE BLACK STAINING ON THE SUPERIOR SURFACE, WEAR OF ARTICULAR BEARING SURFACE OF INTERNAL PROSTHETIC LEFT HIP JOINT, INITIAL ENCOUNTER (CMS/HCC). HAD SEVERE BACK PAIN/MUSCLE SPASMS. COBALT LEVEL OF 77.1 AND A CHROMIUM LEVEL OF 40.1. DURING THE PROCEDURE, APPROXIMATELY 9 ML OF YELLOWISH FLUID WERE REMOVED. MODERATE AMOUNT OF SCAR TISSUE WHICH WAS STAINED BLACK CONSISTENT WITH A METAL STAINING. SCAR TISSUE WAS EXCISED AROUND THE TRUNNION AND THE ACETABULUM CIRCUMFERENTIALLY. LEFT HIP SORENESS, WEAKNESS, AND DECREASED RECALL OF POSTERIOR. FIBROSIS, FOCAL INFARCTION AND HISTIOCYTIC REACTION SPECIMEN SUBMITTED AS SYNOVIAL SCAR TISSUE CONSISTS OF AN IRREGULAR RUBBERY SEGMENT OF TAN GRAY-RED SOFT TISSUE RECEIVED IN FORMALIN MEASURING

  Patient problems: Adhesion(s); Discomfort; Fatigue; Foreign Body Reaction; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 23692640 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO INFECTION. DOI- UNKNOWN, DOR (B)(6) 2025, AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23623761 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME TO CLINIC COMPLAINING OF A NEW PAIN IN LEFT HIP THAT WAS PRESENTED FOLLOWING A LONG ROAD TRIP. THE HIP WAS ASPIRATED AND THE CULTURE RETURNED POSITIVE. THE SURGEON FELT THAT I&D WITH HEAD AND POLY EXCHANGE AND PLACEMENT OF ANTIBIOTIC BEADS WOULD BE BEST FOR THE PATIENT. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23316722 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22505797 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED HIP. SURGEON PERFORMED I&D OF HIP WITH HEAD/LINER EXCHANGE. THERE WAS NO DELAY AND NO COMPLAINTS. ITEMS UNAVAILABLE FOR RETURN. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22337268 ↗
• InjuryMay 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION OF CONSTRAINED LINER. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22108060 ↗
• InjuryJan 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH PINNACLE CONSTRAINED LINER EXCHANGE DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21126731 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2014. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 20798510 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 19760973 ↗
• InjuryJun 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REMOVED WELL FIXED CUP, WELL FIXED LINER AND WELL FIXED HEAD DUE TO INSTABILITY. SURGEON REVISED IN ORDER TO CHANGE CUP POSITIONING TO ADD STABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Joint Laxity

  MAUDE report 19493641 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE THA IMPLANTS WERE REPLACED WITH A PROSTALAC HIP. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6), 2010, DOR: (B)(6), 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18334175 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: ON (B)(6) 2012: POST-OPERATIVE XRAY SHOWING PERIPROSTHETIC OSTEOLYSIS AROUND THE PROXIMAL ASPECT OF THE RIGHT FEMORAL STEM WHICH IS UNCHANGED FROM PREVIOUS STUDY ON (B)(6) 2012. A NEW SUTURE ANCHOR IS IDENTIFIED WITHIN THE RIGHT GREATER TROCH WITH PERIARTICULAR GAS WHICH IS LIKELY POSTOPERATIVE ON (B)(6) 2012: INDICATION IS WEAR OF PROSTHETIC JOINT BUT NO FINDINGS PROVIDED ON (B)(6) 2012: PERSISTENT LUCENCY ADJOINING THE PROXIMAL RIGHT FEMORAL STEM MEASURING UP TO 6 MM LATERALLY WITH SOME PROGRESSION FROM THE LAST STUDY. SUSPICIOUS FOR LOOSENING OF THE PROXIMAL RIGHT FEMORAL STEM AFFECTED SITE: RIGHT HIP.

  Patient problems: Osteolysis; Swelling/ Edema

  MAUDE report 17894375 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THE SURGEON REMOVED HEAD AND LINER, WASHED OUT THE JOINT AND REPLACED WITH NEW HEAD AND LINER. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17844074 ↗
• InjurySep 28, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD SUFFERED A FALL AND DISLOCATED THE HIP. SURGEON BELIEVED THE POLY MAY HAVE DISLODGED FROM THE CUP FOLLOWING THE FALL. THE POLY HAD DISLODGED FROM THE CUP, SO SURGEON DECIDED TO REPLACE WITH THE SAME SIZE POLY AND HEAD SINCE THE PATIENT'S SIZING HAD SEEMED TO BE CORRECT AFTER THE FIRST SURGERY. TIME WAS NOT EXTENDED. THE PATIENT HAD METALLOSIS IN THE HIP FROM THE HEAD AND LINER RUBBING ON EACH OTHER WHILE THE LINER WAS OUT OF THE CUP. MOST OF THE WEAR LOOKED TO BE FROM THE CERAMIC HEAD. MOST OF THE PINK COATING FROM ONE SIDE WAS WORN OFF. SURGEON WASHED IT OUT AND REPLACED IMPLANTS. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Foreign Body Reaction; Joint Dislocation

  MAUDE report 17840799 ↗
• InjurySep 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORDS REPORTED THAT ON (B)(6) 2013, THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2012: DOR: (B)(6) 2023; LEFT HIP.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 17744696 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO STABILITY ISSUES AND THE HEAD/LINER WERE CHANGED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 17395586 ↗
• InjuryJul 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2023, AFTER EXPERIENCING A DISLOCATION. SURGICAL DELAY IS UNKNOWN. DATE OF IMPLANT WAS (B)(6) 2023. THIS REPORT IS FOR A DLT TS CER HD 12/14 36MM +8.5. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 17297905 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS RECORDS STATED THAT ON 12/20/2021, PATIENT HAD RIGHT HIP REVISION DUE TO HEAVY METAL POISONING FROM TOXIC HEAVY METALS. ALSO ALLEGES INJURY, PAIN, TISSUE DESTRUCTION, METAL WEAR, LOSS OF ENJOYMENT OF LIFE AND LIMITATION OF DAILY ACTIVITIES. OPERATIVE NOTED THAT THE PATIENT HAD COMPETITOR IMPLANTS ALONG WITH DEPUY DELTA CERAMIC HEAD WERE IMPLANTED IN RIGHT HIP. THIS REVISION WAS CAPTURED IN (B)(4). . MEDICAL RECORDS REPORTED THAT ON 01/28/2022, THE PATIENT HAD AN IRRIGATION AND DEBRIDEMENT OF RIGHT HIP TO ADDRESS INFECTION WITH WOUND DRAINAGE. THE INDICATIONS FOR SURGERY INCLUDED INCREASE IN SWELLING, PAIN, AND SPONTANEOUS DRAINAGE FROM HIS RIGHT HIP 4 WEEKS AFTER REVISION. DURING THE PROCEDURE, THE SURGEON REPORTED OBSERVING A SMALL AREA OF DEHISCENCE. DOI(HEAD): (B)(6) 2021 ; DOE: (B)(6) 2022 ; RIGHT HIP.

  Patient problems: Fluid Discharge; Pain; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 16805975 ↗