BIOLOX DELTA 1365-28-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10603295033301), received between Sep 11, 2017 and Mar 6, 2026 — classified as 41 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION, EXPLANTED ALL COMPONENTS FOR I AND D. THERE WAS NO DELAY IN THE CASE, THERE WAS NO HARM DONE TO THE PATIENT, THERE WERE NO COMPLAINTS. I HAD NO FURTHER INFORMATION LAST REVISION WAS (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24531155 ↗
• InjuryJan 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT PRESENTS IN ER WITH DISLOCATED HIP POST TOTAL FEMUR REPLACEMENT. HEAD AND LINER WERE REPLACED WITH NO DELAY NOR PATIENT HARM. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24007509 ↗
• InjuryDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS A HEAD AND LINER EXCHANGE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 23865981 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LINER AND HEAD WAS REMOVED AND REVISION WAS DONE DUE TO INFECTION. DOI (B)(6) 2025, DOR (B)(6) 2025, AFFECTED SIDE- LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 23101150 ↗
• InjurySep 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED WITH LINER AND HEAD DUE TO DISLOCATION. LINER DISASSOCIATED FROM CUP. THERE WAS A CONSTRAINED ACETABULAR LINER AT UNKNOWN INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22995020 ↗
• InjuryJul 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED, THE FEMORAL HEAD AND THE CONSTRAINED LINER NEEDS TO BE EXPLANTED. NEW IMPLANTS WERE PUT IN THEIR PLACE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22394185 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTED HIP. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20524536 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS SICK AND HAD ELEVATED NUMBERS SO SURGEON DECIDED TO TAKE HER BACK AND WASH HER OUT SWAPPING THE HEAD AND CONSTRAINED LINER. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19742007 ↗
• InjuryJun 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. THE SURGEON REVISED TO A CONSTRAINED PINNACLE JUST DISLOCATED FROM LOCKED LINER AND PLAN TO CONVERT TO A DUAL MOBILITY, WHICH WASN'T AN OPTION IN 1/2 - NOTED NOTCHING ON FEMORAL NECK CONVERTED PINN. THERE WAS NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 19568587 ↗
• InjuryMay 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO A DISLOCATED HIP POST TOTAL FEMORAL REPLACEMENT WITH A CONSTRAINED LINER. LINER AND HEAD ARE REPLACED UNEVENTFULLY WITH NO DELAY OR PATIENT HARM NOTED. DOI: (B)(6) 2024, DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 19221434 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. SURGEON REMOVED CUP AND DUAL MOBILITY AND PLACED COMPETITOR IMPLANTS WITH OUR HEAD. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 19126050 ↗
• InjuryFeb 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED. ALL IMPLANTS WERE REMOVED. THERE WAS NO ADDITIONAL TIME ADDED TO THE CASE. THE PATIENT WASN'T HARMED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6), 2023, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18711448 ↗
• InjuryJan 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 18475807 ↗
• InjuryNov 14, 2023Fracture; Fracture

  PATIENT WAS PREVIOUSLY REVISED DUE TO BROKEN CERAMIC ON CERAMIC BEARING TO POLY LINER. EVERYTHING REMOVED DUE TO INFECTION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6), 2023, DOR: (B)(6), 2023, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 18136853 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH INFECTION SO REMOVED ALL IMPLANTS TO ALLOW FOR INFECTION TO CLEAR. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023, DOR: UNKNOWN, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18093910 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION. THE HEAD WAS SWAPPED FOR ONE THE SAME SIZE. DOE: (B)(6) 2023 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18054652 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO MAJOR SPINE HARDWARE AND PELVIC MOBILITY ISSUES. PATIENT DISLOCATED AND CUP BECAME UNSTABLE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 17439827 ↗
• InjuryJun 9, 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: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17097682 ↗
• MalfunctionFeb 27, 2023Difficult to Insert; Difficult to Insert

  REVISION TS (B)(6) 28 +1.5 HEAD DIDN¿T FIT ONTO ACTIS STEM IN A HEAD EXCHANGE. DOCTOR THOUGHT TAPER WAS WRONG. OPENED ANOTHER TS HEAD AND THE DOCTOR SWITCHED TO A METAL HEAD BECAUSE THE SECOND REVISION HEAD WASN¿T FITTING EITHER. THERE WAS A TEN MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 16442596 ↗
• MalfunctionFeb 27, 2023Difficult to Insert; Difficult to Insert

  REVISION TS 12/14 28 +1.5 HEAD DIDN¿T FIT ONTO ACTIS STEM IN A HEAD EXCHANGE. DOCTOR THOUGHT TAPER WAS WRONG. OPENED ANOTHER TS HEAD AND THE DOCTOR SWITCHED TO A METAL HEAD BECAUSE THE SECOND REVISION HEAD WASN¿T FITTING EITHER. THERE WAS A TEN MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 16442587 ↗
• InjuryJan 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HEAD CAME THROUGH CONSTRAINED POLY DURING PT. ADDING LENGTH. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16112850 ↗
• InjurySep 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SECOND REVISION COMPLETED DUE TO DISLOCATION. DOI- (B)(6) 2022. DOR- (B)(6) 2022. AFFECTED SIDE- LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15335051 ↗
• InjuryMay 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION OF HIP. SURGEON EXPLANTED CONSTRAINED LINER REVISING WITH LONGER HEAD AND 10DEG LINER. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14381714 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. RESECTION ARTHROPLASTY AND GIRDLE STONE. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14213297 ↗
• InjuryApr 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FREQUENT DISLOCATIONS. PATIENT HAS A FUSED SPINE, CAUSING STIFFNESS. PATIENT DISLOCATED CONSTRAINED LINER. REMOVED LINER, CUP AND HEAD, LEFT ACTIS STEM WELL FIXED IN PATIENT. PATIENT RECEIVED A COMPETITORS CUP, DUAL MOBILITY LINER AND A DEPUY TS 28MM HEAD. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Muscular Rigidity

  MAUDE report 14167668 ↗