BIOLOX DELTA 1365-28-330Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10603295033295), received between Aug 28, 2017 and Sep 30, 2026 — classified as 44 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 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 46 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Dislodged or Dislocated

  It was reported that replaced original stem with one larger in size and changed out the poly liner and head.DOI-Unknown,DOR-(b)(6)2026,Affected side- Unknown.

  Patient problems: Joint Dislocation

  MAUDE report 50945288 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with infected total hip needing head and liner exchange.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50695415 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A HEMATOMA AND SURGEON ELECTED TO WASHOUT AND CHANGE MODULAR COMPONENTS. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE- RIGHT HIP.

  Patient problems: Hematoma

  MAUDE report 24691246 ↗
• InjuryMar 2, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24482582 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24214816 ↗
• InjuryDec 22, 2025Noise, Audible; Noise, Audible

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

  Patient problems: Ambulation or Postural Difficulties; Cellulitis; Discomfort; Foreign Body Reaction; Pain; Physical Asymmetry

  MAUDE report 23866213 ↗
• InjuryDec 1, 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 INFECTION. DOCTOR DID I&D HEADBALL LINER SWAP. NO ADDITIONAL INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23686889 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SWAPPED SELF-CENTERING BIPOLAR AND FEMORAL HEAD AFTER DRAINING SURGICAL SITE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 23290897 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE LEFT HIP IS THE AFFECTED SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 23025052 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AFTER PRIMARY THA. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22688638 ↗
• InjuryJun 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT IMPLANTS NEEDED TO BE REVISED BECAUSE HIP WAS DISLOCATING AND UNSTABLE. PATIENT NEEDED A CONSTRAINED LINER. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22345835 ↗
• InjuryApr 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A DISLOCATION OF THE 28MM ID HEAD FROM THE 53MM OD DUAL MOBILITY HEAD. THE SURGEON REMOVED THE IMPLANTED 28MM HEAD AND THE 53MM DM HEAD AND REPLACED IT WITH A 28MM +12.5 ID HEAD AND A NEW 53MM OD HEAD. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21764716 ↗
• InjuryMar 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2015, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21733469 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION OF A RECLAIM BIMENTUM WAS DONE. THE REASON FOR REVISION WAS DUE TO INSTABILITY. THE PATIENT PREVIOUSLY HAD A GIRDLESTONE PROCEDURE, AND WAS LIKE THAT FOR A NUMBER OF YEARS. THE SURGEON NOTED THAT DURING THE PRIMARY SURGERY THEY WERE STABLE ON THE TABLE WITH A 24X95 RECLAIM BODY, BUT THEIR ADDUCTOR MUSCLES WERE GONE, AND SURROUNDING TISSUES WERE DYSFUNCTIONAL. AT SOME POINT AFTER SURGERY PATIENT MOVED INTO A POSITION (WHICH THE SURGEON ADVISED NOT TO) AND THEY DISLOCATED. THE RECLAIM BODY, BIMENTUM POLY AND 28+8.5 CERAMIC HEAD WERE REMOVED. CUP WAS RETAINED. THEN A LONGER BODY, NEW POLY AND 28+12 HEAD WERE IMPLANTED. THE SURGEON SAID THAT THE PATIENT'S SOFT TISSUES ARE VERY POOR, AND THEY HAVE NO ADDUCTOR MUSCLES. NO PREVIOUS REVISION HAD BEEN DONE FOR DISLOCATIONS. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 21696091 ↗
• InjuryFeb 10, 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 INFECTION AND THE SURGEON DID A SINGLE STAGE REVISION. SURGEON REMOVED ALL IMPLANTS, DID A THOROUGH I&D, AND PUT IN NEW IMPLANTS. THERE WAS NO DELAY IN PROCEDURE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21342925 ↗
• MalfunctionDec 31, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT DURING A RECENT PACKAGING INTEGRITY CONFERENCE, IT WAS IDENTIFIED THAT SIX ITEMS ARE WITHOUT TRACEABILITY AND NATIONALIZATION LABELS. IT WAS NOT POSSIBLE TO DETERMINE EXACTLY WHEN THE LABELS WERE LOST, BUT THEIR ABSENCE WAS DETECTED DURING THE VERIFICATION PROCESS. WHEN THESE PRODUCTS WERE RECEIVED IN STOCK, WITH THE RECEIPT NOTE INVOICE (FIRST ENTRY), THERE WAS NO CLAIM RECORD REGARDING THE LACK OF LABELS, WHICH LEADS US TO CONCLUDE THAT THE ITEMS WERE PROPERLY LABELED AT THE ENTRANCE.

  Patient problems: Insufficient Information

  MAUDE report 21048382 ↗
• InjuryJun 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A BHA WITH THE BIPOLAR CUP AND THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2024, A REVISION SURGERY WILL BE PERFORMED BECAUSE OF DISLOCATION. IT WILL BE REPLACED WITH PINNACLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 19533051 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ACETABULAR LINER AND FEMORAL HEAD DUE TO DISLOCATION AND PAIN. LIGHT BURNISHING NOTED ON INTERIOR OF THE SHELL, DUE TO CERAMIC CONTACT. SURGEON DETERMINED THIS WAS NOT OF CONCERN. OLD LINER AND HEAD REMOVED AND REPLACED WITH NEW COMPONENTS. JOINT RESTORED STABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18668060 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S HEAD AND LINER WERE EXCHANGED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE : RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18552961 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: 1. WHAT WAS THE EXACT ALLEGATION AGAINST THE DEVICES? WHAT WAS THE REASON FOR REVISION? INFECTION. 2. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NONE. 3. WAS THERE ANY PATIENT HARM RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE DETAILS. NONE.

  Patient problems: Unspecified Infection

  MAUDE report 18518043 ↗
• InjuryDec 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/21/2018 CLOSED DISLOCATION OF RIGHT HIP, PATIENT REPORTED HAVING RIGHT HIP PAIN. PATIENT WAS NOTED TO HAVE HAD HIP SURGERY 2 WEEKS AGO FOR REMOVAL OF PSEUDOTUMOR HIP REPLACEMENT. ON 05/21/2021, MEDICAL RECORDS NOTE THE PATIENT HAS RIGHT HIP PAIN. ON 03/23/2023, THE PATIENT HAD A RIGHT SACROILIAC JOINT INJECTION TO ADDRESS PAIN IN RIGHT HIP AND SACROILIITIS.

  Patient problems: Hypersensitivity/Allergic reaction; Joint Dislocation; Pain

  MAUDE report 18325674 ↗
• InjuryNov 6, 2023Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THE CERAMIC HEAD WAS RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 18074460 ↗
• InjuryJun 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. THE SURGEON WENT UP A HEAD SIZE FROM 8.5 TO 12. NO INSTRUMENTS WERE BROKEN DURING SURGERY. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17172794 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF PFR AND BIPOLAR HEAD DUE TO INFECTION. WASHED OUT AND REIMPLANTED NEW COMPONENTS. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15249301 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE HIP. SURGEON EXPLANTED ALL COMPONENTS REVISING WITH NEW STEM AND CUP W/CONSTRAINED LINER. THERE WAS NO SURGICAL DELAY. DOI: APR 13, 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 14852811 ↗