BIOLOX DELTA 1365-40-740Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10603295033721), received between Aug 16, 2017 and Sep 29, 2026 — classified as 56 injuries, 2 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Device Dislodged or Dislocated

  It was reported that Due to dislocation, Dr. removed head, cup and liner and replaced with competitor cup and liner and new Depuy head.DOI: on (b)(6) 2026,DOR: on (b)(6) 2026,Affected side: Left.

  Patient problems: Joint Dislocation

  MAUDE report 50931197 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to Instability.DOI Unknown.DOR (b)(6) 2026.Affected side-Left.

  Patient problems: Joint Laxity

  MAUDE report 50715980 ↗
• InjuryAug 17, 2026Device Dislodged or Dislocated

  It was reported that the patient was dislocated. Cup, head and liner were explanted and replaced with a larger DM construct.DOI: (b)(6) 2025.DOR: (b)(6) 2026.Affected side: Right hip.

  Patient problems: Joint Dislocation

  MAUDE report 50283824 ↗
• InjuryJul 28, 2026Device Dislodged or Dislocated

  It was reported that patient had Constant dislocations.DOI- (b)(6) 2025.DOR- (b)(6) 2026.Affected side- Right Hip.

  Patient problems: Joint Dislocation

  MAUDE report 50060680 ↗
• InjuryMay 12, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE-LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25148384 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAS A LEFT TOTAL HIP THAT IS INFECTED. ALL COMPONENTS WERE REMOVED. PATIENT HAS MULTIPLE SURGERY DATES, (B)(6) 2020. (B)(6) 2022. (B)(6) 2025. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22176930 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEAD AND LINER WERE EXCHANGED. CAUSE OF PAIN WAS UNKNOWN. SURGERY DATE WAS ALSO UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 20320957 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE CUP REVISED FOR INSTABILITY. ALL WELL FIXED. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Joint Laxity

  MAUDE report 18441006 ↗
• InjuryOct 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. SWAPPED OUT POLY LINER FOR CONSTRAINED LINER. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17966220 ↗
• MalfunctionAug 17, 2023No Apparent Adverse Event; Missing Information; No Apparent Adverse Event; Missing Information

  IT WAS REPORTED THAT SET MISSING COMPONENT, BILL OF MATERIAL SHOWS COMPONENT SHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17567700 ↗
• InjuryJul 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD HIP DONE ON (B)(6) 2017 AT THE HOSPITAL BY THE SURGEON. PATIENT HIP HAD RECENTLY BECOME DISLOCATED. THE SURGEON FELT THE PATIENT WOULD BENEFIT FROM CONVERTING THE HIP TO A CONSTRAINED LINER FOR INCREASED STABILITY. A TRIAL REDUCTION WAS PERFORMED WITH A 60X36 +4 NEUTRAL TRIAL AND A 36MM +8.5 HEAD TRIAL. THIS WAS FOUND TO BE STABLE. THE REAL LINER AND FEMORAL HEAD WAS OPENED AND IMPLANTED. HIP WAS REDUCED AND THE LOCKING RING WAS PLACED APPROPRIATELY. HIP STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17324347 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS HEAD & LINER EXCHANGE. THERE WAS NO LOOSENING REPORTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16843760 ↗
• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO POSSIBLE INFECTION AND SURGEON ELECTED TO DEBRIDE AND CHANGE HEAD, LINER AND HOLE COVER. IT WAS UNKNOWN IF THERE ANY SURGICAL DELAY OR NOT. DOI: (B)(6) 2015. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16618822 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR REMOVAL OF TOTAL HIP AND PLACEMENT OF PROSTALAC ARTICULATING ANTIBIOTIC SPACER DUE TO THE PRESENCE OF INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2022 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16529374 ↗
• InjuryJan 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LINER AND HEAD WERE THE ONLY ITEMS REMOVED FOR A REVISION. THERE WERE NO VISIBLE DEFECTS WITH THE IMPLANTS. THE PATIENT WAS DISLOCATING WHICH WAS THE REASON FOR THE REVISION SURGERY. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 16183661 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 PHYSICAL THERAPY NOTES STATING THE LEFT HIP DEMONSTRATES AN EFFUSION AND THE PATIENT HAS RECENTLY FALLEN. PHYSICAL THERAPY NOTES ON (B)(6) 2021 STATE THE LEFT HIP IS VERY SWOLLEN, RED, AND HARD. THE PATIENT ALSO STATES HE MAY HAVE HAD A LOW GRADE FEVER. THE TREATMENT WAS NOT COMPLETED DUE TO CONCERNS OVER INFECTION. NOTES DETAIL A PHYSICAL THERAPY EVALUATION PERFORMED ON (B)(6) 2021. THE NOTES STATE THE LEFT HIP IS BRUISED WITH A SIGNIFICANT EFFUSION. THIS PC WAS CREATED TO CAPTURE THE HARM REPORTED POST LEFT HIP REVISION ON (B)(6) 2021.

  Patient problems: Ecchymosis; Erythema; Fall; Fever; Swelling/ Edema; Unspecified Infection

  MAUDE report 16111804 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONVERSION FROM TOTAL HIP TO PROSTALAC FOR POSSIBLE INFECTION. DOE: (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 14851927 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. I&D WAS COMPLETED. POLY AND HEAD WERE EXCHANGED. DOI: UNKNOWN. DOR: (B)(6) 2022. RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13592387 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13175044 ↗
• MalfunctionOct 22, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT A SIZE 40 MM + 12 MM CERAMIC HEAD BALL ( 1365-40-740) WAS CHOSEN TO BE IMPLANTED ONTO AN ACTIS SIZE 10 STEM (1010-11-100). THE HEAD BALL WOULD NOT PROPERLY SEAT ONTO THE STEM. IT WAS AS IF THE TAPERS WERE DIFFERENT. A METAL HEAD BALL OF THE SAME SIZE WAS THEN OPEN AND IMPLANTED WITHOUT ISSUE. THE SURGEON AND PA THOUGHT THAT THE IMPLANT WAS DEFECTIVE IN SOME WAY. IT WAS ALSO INDICATED THAT THERE WAS A SURGICAL DELAY OF 15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682971 ↗
• InjuryAug 26, 2021Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD AN LPS PROXIMAL FEMORAL REPLACEMENT RECENTLY AND DISLOCATED. A ZIMMER ACETABULAR CUP WAS ALREADY IN THERE SO HIP WAS CONVERTED TO A ZIMMER CONSTRAINED LINER AND HEAD WAS CHANGED TO ACCOMMODATE SIZING. DOI: (B)(6) 2021. DOR: (B)(6) 2021. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12371041 ↗
• InjuryAug 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. DOR: (B)(6) 2021 LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12275952 ↗
• InjuryJul 28, 2021Adverse 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. ALL COMPONENTS WERE REMOVED. DOI: UNKNOWN; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 12240114 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD WASHOUT DUE TO INFECTION. NEW HEAD IMPLANTED. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2021; RIGHT HIP.

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

  MAUDE report 12122068 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PRESUMED CUP INSTABILITY. CUP WAS STABLE IN INGROWN. REPLACED HEAD AND LINER. DOI: (B)(6) 2019; DOR: (B)(6) 2021: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 12108186 ↗