BIOLOX DELTA 1365-40-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 10603295033691), received between Jul 24, 2017 and Jun 22, 2026 — classified as 166 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (55 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 170 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A ONE STAGE REVISION HIP TO TREAT INFECTION. PATIENT CONTINUES TO HAVE DRAINAGE POST SURGERY SO SURGEON CHOSE TO BRING PATIENT BACK TO THE OR TO TREAT. A THOROUGH I&D WAS PERFORMED AND NO ACTIVE BLEEDING WAS FOUND. THE SURGEON HAD ELECTED TO CHANGE THE HEAD AND LINER AND PLACE RESORBABLE ANTIBIOTIC BEADS AS A PRECAUTION. NO PATIENT HARM NOR DELAY WAS NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENTS. AFFECTED SIDE-LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 25576079 ↗
• InjuryJun 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO TRAUMATIC DISLOCATION FROM MULTIPLE FALLS. AFFECTED SIDE: RIGHT.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 25382485 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25318955 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REVISED FOR INSTABILITY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25232526 ↗
• InjuryApr 27, 2026Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE LEFT IS THE AFFECTED SIDE AND PATIENT PUSHED TOO HARD TOO FAST AFTER SURGERY AND WASN'T FULLY HEALED BEFORE RESUMING REGULAR PHYSICAL ACTIVITY.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 25003476 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A WASHOUT WAS PERFORMED DUE TO A PREVIOUS INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE-LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24998206 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION DUE TO WHICH ALL THE COMPONENTS WERE EXPLANTED AND SPACER IMPLANTED. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24753321 ↗
• InjuryMar 2, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT HEAD AND LINER REVISED FOR DISLOCATION. NO DELAYS NO HARM TO PATIENT NO BROKEN INSTRUMENT. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24490062 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR INFECTION. DOI- (B)(6) 2026. DOR- (B)(6) 2026. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24443346 ↗
• InjuryFeb 20, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS DISLOCATING. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24403447 ↗
• InjuryFeb 11, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. NO PREVIOUS HIP REVISION OTHER THAN CLOSED REDUCTION. DOI: (B)(6) 2023, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24317371 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A RTHA ON (B)(6) 2024 DUE TO A FEMORAL NECK FRACTURE. THEY PRESENTED WITH AN INFECTION. THE HEAD AND LINER WERE REPLACED IN ORDER TO WASH OUT THE INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24210503 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HEAD/LINER EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2025 DOR: (B)(6), 2026 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24168729 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SUFFERED FROM INFECTION DUE TO IMPLANT. DOI- (B)(6) 2025. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24116599 ↗
• InjuryJan 14, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING. DOCTOR WANTED TO INCREASE HEAD SIZE AND POLY OFFSET. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24072582 ↗
• InjuryJan 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A POST-OPERATIVE DISLOCATION WHICH RELATES TO SPINOPELVIS VERSUS SOFT TISSUE. DOI: (B)(6) 2024, DOR- UNKNOWN, AFFECTED SIDE- LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24059952 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEPTIC. DURING AN ATTEMPTED IRRIGATION AND DEBRIDEMENT, THE INFECTION WAS FOUND TO BE WORSE THAN ANTICIPATED, LEADING TO THE REMOVAL OF ALL IMPLANTS AND PLACEMENT OF ABX (ANTIBIOTIC) SPACER BLOCKS FOR A PLANNED STAGED REVISION. ALL DEVICES WERE EXPLANTED WITHOUT DIFFICULTY. AFTER IMPLANTATION AND REDUCTION OF THE ANTIBIOTIC SPACER, THE PATIENT WAS CODED. DOI: (B)(6) 2025, DOR: UNKNOWN , AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23966454 ↗
• InjuryDec 11, 2025Migration; Migration

  VOLUNTARY REPORT RECEIVED (MW5178318). I AM REPORTING SERIOUS HARM AND PRODUCT TRACEABILITY ISSUES INVOLVING HIP IMPLANTS USED IN TWO SEPARATE SURGERIES THAT APPEAR TO INVOLVE JOHNSON & JOHNSON/DEPUY SYNTHES DEVICES. BOTH SURGERIES RESULTED IN COMPLICATIONS, PAIN, AND DISABILITY, AND IN BOTH CASES THE IMPLANTS LACKED PROPER IDENTIFICATION OR TRACEABLE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION. FIRST SURGERY ¿ (B)(6) 2024 ((B)(6) HOSPITAL, MD): A JOHNSON & JOHNSON/DEPUY REPRESENTATIVE NAMED (B)(6) WAS PRESENT IN THE OPERATING ROOM. THE SURGEON SIGNED OFF ON THE IMPLANT EVEN THOUGH THE IMPLANT SHEET DID NOT CONTAIN SPECIFIC SERIAL OR UNIQUE DEVICE IDENTIFIER (UDI) NUMBERS. THE IMPLANT HAD NO IDENTIFIABLE MARKINGS, MAKING IT COMPLETELY UNTRACEABLE. THIS VIOLATES STANDARD FOOD AND DRUG ADMINISTRATION (FDA) AND HOSPITAL TRACEABILITY RULES. POST-OPERATIVELY, I EXPERIENCED PAIN, INSTABILITY, AND NUMBNESS IN MY LEG. WHEN LATER REVISION SURGERY WAS PERFORMED, THE IMPLANT WAS FOUND TO BE AT A 36-DEGREE ANGLE, IMPROPERLY FITTED, AND FRACTURED, CONFIRMING MECHANICAL AND QUALITY FAILURE. SECOND (REVISION) SURGERY ¿ (B)(6) 2025 ((B)(6) HOSPITAL, (B)(6)): THE REVISION SURGEON, DR. (B)(6), DOCU

  Patient problems: Joint Laxity; Loss of Range of Motion; Numbness; Pain

  MAUDE report 23778982 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VOLUNTARY REPORT RECEIVED (MW5178318) I AM REPORTING SERIOUS HARM AND PRODUCT TRACEABILITY ISSUES INVOLVING HIP IMPLANTS USED IN TWO SEPARATE SURGERIES THAT APPEAR TO INVOLVE JOHNSON & JOHNSON/DEPUY SYNTHES DEVICES. BOTH SURGERIES RESULTED IN COMPLICATIONS, PAIN, AND DISABILITY, AND IN BOTH CASES THE IMPLANTS LACKED PROPER IDENTIFICATION OR TRACEABLE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION. FIRST SURGERY Â (B)(6) 2024 ((B)(6) HOSPITAL, MD): A JOHNSON & JOHNSON/DEPUY REPRESENTATIVE NAMED (B)(6) WAS PRESENT IN THE OPERATING ROOM. THE SURGEON SIGNED OFF ON THE IMPLANT EVEN THOUGH THE IMPLANT SHEET DID NOT CONTAIN SPECIFIC SERIAL OR UNIQUE DEVICE IDENTIFIER (UDI) NUMBERS. THE IMPLANT HAD NO IDENTIFIABLE MARKINGS, MAKING IT COMPLETELY UNTRACEABLE. THIS VIOLATES STANDARD FOOD AND DRUG ADMINISTRATION (FDA) AND HOSPITAL TRACEABILITY RULES. POST-OPERATIVELY, I EXPERIENCED PAIN, INSTABILITY, AND NUMBNESS IN MY LEG. WHEN LATER REVISION SURGERY WAS PERFORMED, THE IMPLANT WAS FOUND TO BE AT A 36-DEGREE ANGLE, IMPROPERLY FITTED, AND FRACTURED, CONFIRMING MECHANICAL AND QUALITY FAILURE. SECOND (REVISION) SURGERY Â (B)(6) 2025 ((B)(6) HOSPITAL, (B)(6)): THE REVISION SURGEON, DR. (B)(6), DOCUMEN

  Patient problems: Loss of Range of Motion; Nerve Damage; Pain

  MAUDE report 23771408 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23620098 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR HIP IRRIGATION AND DEBRIDEMENT WITH HEAD/POLY EXCHANGE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23389617 ↗
• MalfunctionSep 9, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT. THE 40 1.5 FEMORAL HEAD IMPLANT HAD BLUE FUZZ INSIDE OF IT. IT WAS DISCOVERED IMMEDIATELY UPON THE SURGICAL TECH OPENING THE HEAD; THE FUZZ COULD NOT HAVE COME FROM SOMEWHERE ELSE. THE SURGEON PREFERRED A NEW FEMORAL HEAD, SO A SECOND IMPLANT WAS OPENED. DOE: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003914 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 22743258 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD REVISION SURGERY; INFECTED/ POLY AND HEAD EXCHANGE. DOI: (B)(6) 2025, DOR: UNKNOWN, AFFECTED SIDE: UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 22729520 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED, ALL IMPLANTS WERE EXTRACTED AND ANTIBIOTIC BEADS WERE IMPLANTED. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22686950 ↗