BIOLOX DELTA 1365-32-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 314 adverse event reports that list this exact device (DI 10603295033448), received between Jun 28, 2017 and Sep 23, 2026 — classified as 1 death, 308 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (138 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 314 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient is unstable. The cup and liner were taken out and their position was changed during a revision procedure.DOI: (b)(6) 2010.DOR:(b)(6) 2026.Affected side: Left hip.

  Patient problems: Joint Laxity

  MAUDE report 50873114 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to I&D with head & liner exchange due to suspected infection.DOI:(b)(6) 2026,DOR: (b)(6) 2026,Affected Side: Right.

  Patient problems: Unspecified Infection

  MAUDE report 50731591 ↗
• InjuryJul 30, 2026Noise, Audible

  It was reported that patient had a revision hip procedure through a direct lateral approach. The original hip replacement procedure with Pinnacle Trilock implants was completed 7 years previously. The patient had presented in AE with a two day history of pain, and reported hearing a ¿clunk¿ sound. The revision procedure involved the extraction of a Pinnacle Sector Cup 52mm, a Poly 52/32mm, and a 32mm ceramic head.

  Patient problems: Pain

  MAUDE report 50083534 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH HEAD AND LINER EXCHANGE DUE TO INSTABILITY. ALL PIECES WERE REMOVED. THERE WAS NO DELAY TO THE CASE AND THERE WAS NO HARM DONE TO THE PATIENT. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25676851 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LEG LENGTH ADJUSTMENT. AFFECTED SIDE: LEFT.

  Patient problems: Physical Asymmetry

  MAUDE report 25395841 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS BROUGHT TO OPERATING ROOM FOR AN IRRIGATION AND DEBRIDEMENT. SURGEON EXCHANGED POLYETHYLENE LINER AND FEMORAL HEAD. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968106 ↗
• InjuryApr 15, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED DURING A TOTAL HIP PROSTHESIS, THE SURGEON HAS USED A TOO SMALL FEMORAL HEAD IN A TOO BIG POLY OFFSET LINER. THEREFORE, THE PATIENT NEEDS TO GET REVISED TO CORRECT THE MISMATCH BETWEEN LINER AND FEMORAL HEAD. DOI: (B)(6) 2026. DOE: (B)(6) 2026.

  Patient problems: Insufficient Information

  MAUDE report 24887203 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS COMPLAINING ABOUT SOFT TISSUE IRRITATION AND DR. THOUGHT IT MIGHT BE DUE TO THE SCREW EXTENDING THROUGH BONE AND IN TO SOFT TISSUE. THEY DECIDED TO WASH OUT AND DO A HEAD AND LINER EXCHANGE WHICH HAS RESOLVED HER ISSUE. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inflammation

  MAUDE report 24431875 ↗
• InjuryFeb 24, 2026Naturally Worn; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN DOCTOR CLINIC COMPLAINING OF "SQUEAKING" AFTER A LATE JANUARY 2026 FALL ON HER RIGHT HIP. DOCTOR ELECTED TO REVISE FOR POSSIBLE LOOSE LINER. ON (B)(6) 2026 AT (B)(6) HOSPITAL DOCTOR REVISED THE PATIENTS RIGHT HIP. UPON EXPOSURE TO THE JOINT SPACE THE 32+1 DELTA CERAMIC HEAD WAS FOUND TO HAVE WEAR SUPERIORLY AS A RESULT OF ARTICULATION WITH THE PINNACLE SZ 50 SHELL. THE 50/32 10 DEGREE ALTRX LINER WAS NOT CORRECTLY POSITIONED IN THE ACETABULAR SHELL AND SHOWED SIGNS OF ABNORMAL WEAR. DOCTOR ELECTED TO PUT IN A NEW LINER AND REVISION CERAMIC HEAD THAT MET HIS CRITERIA AND CLOSED THE JOINT SPACE. NO INSTRUMENTS BROKE OR WERE LOST DURING THE CASE. THERE WAS NO SUGGESTION THAT THE PRODUCTS HAD NOT PERFORMED AS THEY HAD EXPECTED TO.

  Patient problems: Fall

  MAUDE report 24426457 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISED DUE TO PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 24221502 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23898009 ↗
• InjuryDec 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS DISLOCATING. SURGEON DETERMINED THAT THE PATIENTS CUP WAS MALPOSITIONED AND OPTED TO REVISE THE ACETABULUM. THE ORIGINAL CUP, LINER, AND 32 CERAMIC HEAD WERE REMOVED AND REPLACED WITH A REVISION CUP FROM ANOTHER MANUFACTURER. A TRIAL REDUCTION WAS PERFORMED WITH 40MM +12 HEAD AND THE HIP WAS STABLE. A 40MM +12 TS CERAMIC HEAD WAS OPENED AND IMPLANTED. STABILITY OF THE HIP WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL - YES, DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23730332 ↗
• InjuryOct 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REVISION WAS PERFORMED BECAUSE THE PATIENT WAS DISLOCATING. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23393643 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 23325796 ↗
• InjuryOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO HIP DISLOCATION AND THE DR. DECIDED TO REVISE TO A CONSTRAINED LINER. IT WAS NOT A PROBLEM WITH THE IMPLANTS OR THE VERSION OF CUP OR STEM. HE WAS GOING TO GO TO A LONGER HEAD TO ADD LENGTH FOR STABILITY BUT DECIDED TO DO THE CONSTRAINED LINER BECAUSE OF THE PATIENT HEALTH. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23297310 ↗
• InjuryAug 22, 2025Naturally Worn; Naturally Worn

  PATIENT HAD A PRIMARY LEFT THR DONE IN TWO YEARS AGO. PATIENT WITH HIGH BMI. THE X-RAY SHOWED AN ABNORMAL POSITION OF THE IMPLANT. SHE WAS REVISITED YESTERDAY (B)(6) 2025. PATIENT WAS REVISED FROM A 32/50 MARATHON +4 10 DEG LINER TO A 28/50 MARATHON LIPPED LINER. THE CERAMIC HEAD WAS CHANGED FROM 32 +5 TO 28 +12 DELTA TS HEAD. NO SURGICAL DELAY. SEVERAL SPECIMENS WERE COLLECTED DURING SURGERY, INCLUDING ONE OF THEM WAS FOR METALLOSIS.

  Patient problems: Foreign Body Reaction

  MAUDE report 22877545 ↗
• InjuryAug 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT PRESENTED WITH A DISLOCATED LEFT TOTAL HIP REPLACEMENT. THE SURGEON ELECTED TO REMOVE THE ORIGINAL HEAD AND LINER CONSTRUCT AND REPLACE IT WITH A CONSTRAINED LINER CONSTRUCT WITH A LONGER FEMORAL HEAD IN AN EFFORT TO KEEP THE HIP LOCATED IN PLACE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22851033 ↗
• InjuryAug 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO CHRONIC DISLOCATIONS. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22796655 ↗
• InjuryAug 8, 2025Noise, Audible; Noise, Audible

  PATIENT UNDERWENT RIGHT THR EIGHTEEN MONTHS PRIOR. PROCEDURE WAS COMPLETED WITH NO PROBLEMS. THE PATIENT HAD TO BE REVISED DUE TO NINE MONTH HISTORY OF CLUNKING/SUBLUXATION AND SIX DAY HISTORY OF SQUEAKING. X-RAY SHOWED LINER DISSOCIATION. INTRAOPERATIVELY, THE LINER SPUN INFERIORLY WITH HEAD ARTICULATING WITH SHELL.

  Patient problems: Joint Laxity

  MAUDE report 22749285 ↗
• InjuryAug 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FELL AND DISLOCATED, REVISED WITH A CONSTRAINED LINER. DOI: (B)(6) 2019, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 22720345 ↗
• InjuryAug 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A RTHA. PATIENT DISLOCATED AND NEEDED TO BE REVISED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 22691751 ↗
• InjuryJun 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22308525 ↗
• InjuryJun 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING. SURGEON TOOK CUP OUT AND PUT EMPHASYS DUAL MOBILITY IN AND INCREASED LENGTH AND OFFSET TO AN 8.5 HEAD. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22192902 ↗
• InjuryJun 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REVISION. SURGEON TOOK OUT THE 48 POROCOAT CUP/LINER AND 32 +5 HEAD AND REPLACED WITH A 54 GRIPTION MULTIHOLE, 54 DUAL MOBILITY LINER WITH A 47/28 OUTER/INNER HEAD. THE OTHER CUP WAS DISLOCATING AND THERE WAS NON-CEMENTED LOOSENING OF THE CUP. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22187305 ↗
• InjuryMay 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S IMPLANT WAS DISLOCATING. REVISED TO +4 10° LINER AND 32+9 HEAD. NO ADDITIONAL INFORMATION WAS AVAILABLE. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED AREA: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22072522 ↗