BIOLOX DELTA 1365-28-730Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295033325), received between Jun 21, 2017 and Sep 10, 2026 — classified as 40 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (22 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 40 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Joint Laxity

  MAUDE report 50720289 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that due to infection, surgeon chose to replace head and liner.DOI: Unknown, DOR: (b)(6) 2026, Affected Side: Unknown Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50547073 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTED HIP; DM HEAD, POLY EXCHANGE, LINER WAS RETAINED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 25533626 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D WAS PERFORMED DUE TO SUSPECTED INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25392621 ↗
• InjuryJan 14, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED. CUP WAS REMOVED AND REVISED TO NEW CUP WITH DUAL MOBILITY. PER SURGEON THE CUP POSITION WAS OVERLY RETROVERTED. PATIENT WAS DETERMINED TO BE STABLE, AND THERE WAS NO PATIENT HARM. THERE WAS NO DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 24073618 ↗
• InjuryNov 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT FELL AND DISLOCATED. NEW CONSTRAINED LINER WAS USED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 23512385 ↗
• InjuryNov 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO A SX FOR A DISLOCATED HIP, DEVELOPED AN INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 23510849 ↗
• InjuryAug 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HEAD EXPLANTED DUE TO DISLOCATION. HEAD WAS FINE. ZIMMER LINER BROKE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 22793022 ↗
• InjuryJul 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A CONSTRAINED LINER IN (B)(6) 2024 DUE TO AN ANTERIOR DISLOCATION. PATIENT REPORTED TO THE ER YESTERDAY WITH ANOTHER DISLOCATION. THE CONSTRAINED LINER WAS BROKEN WHERE THE CONSTRAINING RING MATES WITH THE LINER AND THE HEAD HAD DISASSOCIATED ANTERIORLY. THE CONSTRAINING RING WAS IN PROPER ORIENTATION (CHAMFER TOWARDS ACETABULUM). CUP WAS EXPLANTED AND REVISED TO A LARGER CUP, ALLOWING A BETTER/LARGER DM OPTION OVER CONSTRAINED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22608013 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN I&D OF THE HIP DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21170317 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CORAIL SIZE 14 STD OFFSET IMPLANTED AND SIZE 60 CUP. PATIENT HAD UNDERGONE DAIR PROCEDURE FOR INFECTION IN LATE AUGUST, THIS HAD NOT REMOVED THE INFECTION SO IT WAS DECIDED THAT A FULL REVISION PROCEDURE BE CARRIED OUT. ALL IMPLANTS WERE REMOVED AND RECLAIM WITH MULTIHOLE CUP AND DUAL MOBILITY WAS IMPLANTED AS PART OF THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 21073926 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A CHRONIC INFECTION AND WAS EXPERIENCING DISLOCATION OF HER PREVIOUS CEMENTED SPACER CONSTRUCT WITH A BIPOLAR HEAD. CEMENTED LINER, BIPOLAR OUTER AND INNER HEADS REMOVED. PATIENT WAS WASHED OUT AND THEN PREPPED FOR A MULTIHOLE CUP, 10 DEGREE LINER AND HEAD. NO SURGICAL SLOW DOWNS, DELAYS OR ISSUES. PATIENT STABLE AFTER. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19754289 ↗
• InjuryDec 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HEAD AND DM POLY LINER THAT WERE REMOVED HAD BEEN PLACED ON (B)(6) 2023 DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM OCCURRED. (B)(6). AFFECTED SIDE: LEFT HIP

  Patient problems: Joint Dislocation

  MAUDE report 18364422 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED HIP PROSTHESES WERE REMOVED AND A PROSTALAC WAS PLACED UNEVENTFULLY AFTER A THOROUGH DEBRIDEMENT AND I&D WERE PERFORMED. THE HEAD AND DM POLY LINER THAT WERE REMOVED HAD BEEN PLACED ON (B)(6) 2023 DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM OCCURRED. (B)(6). AFFECTED SIDE: LEFT HIP

  Patient problems: Unspecified Infection

  MAUDE report 18358745 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17702225 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17097073 ↗
• InjuryMay 12, 2023Adverse 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 LACK OF MOTION. SURGEON EXCHANGED POLY AND HEAD. PUT BACK IN SAME POLY AND WENT UP A HEAD SIZE. NO INSTRUMENTS BROKEN DURING SURGERY. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Loss of Range of Motion

  MAUDE report 16920852 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 16831261 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEAD & LINER EXCHANGE DUE TO INFECTION. NEW HEAD AND LINER IMPLANTED. NO FURTHER INFORMATION AVAILABLE. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15233301 ↗
• InjuryMay 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. AND A 32+9 TS CERAMIC AND A 32X50 +4/10 WAS INSERTED . THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14397289 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN IF ANY LOOSENING OR SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 14159918 ↗
• InjuryMar 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNK. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Pain

  MAUDE report 13685026 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUP WAS REVISED DUE TO INSTABILITY. COMPETITOR CUP WAS REMOVED, AND NEW COMPETITOR CUP AND DEPUY HEAD IMPLANTED. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT HIP SIDE.

  Patient problems: Joint Laxity

  MAUDE report 12518894 ↗
• InjuryJul 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A FALL AND ACTUALLY DISASSOCIATED THE HEAD FROM THE LINER. PATIENT WAS BROUGHT BACK FOR REVISION SURGERY AND REVISED TO A NEW CUP AND DUAL MOBILITY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT HIP.

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

  MAUDE report 12122027 ↗
• InjuryJun 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2021, DR REMOVED A GRIPTION ACETABULAR CUP, 2 PINNACLE SCREWS, A PINNACLE MARATHON INSERT, AND A TS REVISION HEAD. THESE COMPONENTS WERE REPLACED BY ANOTHER TS REVISION HEAD, AND A COMPETITOR ALL POLY CEMENTED CUP. REASON FOR REVISION. PATIENT DISLOCATION. SURGEON STATED THIS DISLOCATION WAS UNEXPLAINED AND THAT PATIENT WAS "IN BED". NO FALL REPORTED. OPERATIVE SIDE: RIGHT. NO X-RAYS OR PATIENT NOTES AVAILABLE. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2021 AT (B)(6) HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 11998913 ↗