BIOLOX DELTA 1365-28-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 10603295033288), received between Sep 1, 2017 and Sep 29, 2026 — classified as 72 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (27 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 76 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient required revision of hip implants due to post operative infection. DAIR procedure was carried out.

  Patient problems: Unspecified Infection

  MAUDE report 50931083 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the head and liner were changed for suspected infection, possible metal-on-metal (MoM) reactivity, and a large fibrous fluid collection that was inconclusive with no way to confirm. DOI: (b)(6)2025.DOR: (b)(6)2026.Affected side: Right Hip.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 50071676 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 24872479 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS SHOWING SIGNS OF INFECTION AND SURGEON WANTED TO DO A HEAD AND LINER EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23876826 ↗
• InjuryDec 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATED. THE DOCTOR WENT TO A 12 HEAD BALL. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 23682698 ↗
• InjuryNov 25, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD SURGERY 1 YEAR AGO AND HAD TO BE RE-INTERVENED BECAUSE THE POLYETHYLENE INSERT SPLIT. THE PINNACLE CUP AND POLYETHYLENE INSERT WERE REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 23647919 ↗
• InjurySep 15, 2025Adverse 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 INSTABILITY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 23052991 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SEROMA AND DOCTOR DECIDED TO PERFORM AN I&D AND SWAP THE LINERS AND HEAD. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Seroma

  MAUDE report 22677671 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SHOWING EARLY SIGNS OF INFECTION. HEAD AND LINER SWAP WAS DONE OUT OF AN ABUNDANCE OF CAUTION WHILE PERFORMING THE I&D FOR A POSSIBLY INFECTED HIP. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22422311 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2012, THE PATIENT RECEIVED A RIGHT ANTERIOR APPROACH TOTAL HIP ARTHROPLASTY TO ADDRESS RIGHT HIP OSTEOARTHRITIS. METAL ON METAL IMPLANTS WERE IMPLANTED. THERE WERE NO COMPLICATIONS. ON (B)(6), 2024, PATIENT'S RIGHT HIP WAS REVISED TO ADDRESS ALVAL PSEUDOTUMOR, METALLOSIS, OSSEUS BONE EROSIONS, AND OSTEOLYSIS. THE METAL INSERT AND HEAD WERE REPLACED WITH A DUAL MOBILITY LINER CONSTRUCT. THERE WERE NO COMPLICATIONS. ON (B)(6) 2024, THE PATIENT'S RIGHT HIP WAS REVISED AGAIN TO ADDRESS PURULENT WOUND DRAINAGE, POSSIBLE INFECTION VERSUS ALVAL LESION. CULTURES OBTAINED WERE INCONSISTENT WITH INFECTION, SO THE DIAGNOSIS LEANED IN FAVOR OF ALVAL, SUBSEQUENT TO THE PREVIOUS REVISION. SURGEON REVISED AND REPLACED THE FEMORAL HEAD AND THE DUAL MOBILITY METAL AND POLY LINERS, RETAINING THE ACETABULAR CUP AND FEMORAL STEM. AND EXTENSIVE IRRIGATION AND DEBRIDEMENT WERE PERFORMED. THERE WERE NO COMPLICATIONS. THIS REPORT CAPTURES THE REVISION PROCEDURE ON (B)(6) 2024. THE PREVIOUS REVISION IS CAPTURED ON RELATED COMPLAINT (B)(4). DOI: (B)(6) 2012. DOI: (B)(6) 2024 DOE: (B)(6) 2024.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Osteolysis; Pain; Pocket Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 22161573 ↗
• InjuryJun 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR DISLOCATION. THERE WAS NO HARM TO PATIENT AND NO DELAYS. THERE WAS NO BROKEN INSTRUMENT. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22133690 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISLOCATION OF LEFT HIP, REMOVAL OF DUAL MOBILITY IMPLANTS AND REPLACED WITH A CONSTRAINED LINER. DOI: (B)(6) 2024. DOR: (B)(6) 2025; AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 21971070 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PINNACLE MODULAR MOM LINER REVISION, CONVERTED TO A PINNACLE DUAL MOBILITY ON (B)(6) 2024. THE PATIENT RETURNED TO SURGERY FOR A WASHOUT AND THE PDM IMPLANTS WERE REPLACED AND THE JOINT DEBRIDED AND WASHED OUT. IT IS CURRENTLY UNCLEAR IF THERE IS AN INFECTION, THE LABS ARE PENDING. THERE WERE NO BROKEN INSTRUMENTS, THERE WERE NOT DELAYS. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20588161 ↗
• InjurySep 6, 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 DUE TO POTENTIAL INFECTION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20157185 ↗
• InjuryJul 2, 2024Adverse 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. THE SURGEON DID A WASHOUT WITH LINER AND HEAD EXCHANGE. THE HOSPITAL RETAINED THE COMPONENTS FOR THE PATIENT. DOI- (B)(6) 2022. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19656973 ↗
• InjuryJun 21, 2024Adverse 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. PARTS WERE EXCHANGED. THERE WAS NO DELAY AND NO BROKEN INSTRUMENTS. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19587561 ↗
• InjuryJun 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A NEW CUP PLACED ON THE LISTED DATE DUE TO FAILURE OF LOCKING MECHANISM OF A COMPETITIVE CUP ALONG WITH SUB OPTIMAL POSITIONING. THE SURGEON CHOSE NOT TO UTILIZE THE PROVIDED LOCKING RING TO REDUCE THE CHANCE OF THE CUP BEING PULLED OUT WHILE INGROWTH TOOK PLACE. PATIENT DISLOCATED YESTERDAY AND WAS BROUGHT TO THE OR AND A NEW LINER AND HEAD WERE PLACED WITH THE LOCKING RING WITHOUT DELAY OR PATIENT HARM. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19460394 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? - NO DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18790279 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LEFT HIP INSTABILITY. NO SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE : LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 18596385 ↗
• MalfunctionJan 22, 2024Difficult to Insert; Difficult to Insert

  A SURGEON WAS PERFORMING A TOTAL HIP REPLACEMENT USING OUR BIMENTUM DUAL MOBILITY SYSTEM FOR THE ACETABULAR PORTION. WHEN COMPRESSING THE INNER 28MM HEAD INTO THE 47/28 BIMENTUM LINER THERE WERE TWO AUDIBLE POPS AS NORMAL AND THE INNER HEAD WAS MOVING FREELY INSIDE THE LINER AS IT SHOULD. THIS WAS DONE BY THE SURGEON HIMSELF WHO HAS DONE MANY OF THESE CASES USING THESE SPECIFIC IMPLANTS. ONCE THE HEAD WAS IMPACTED ONTO THE STEM HE NOTICED IT WAS MOVING MORE THAN USUAL. THE IMPLANT SIZES AND EXPIRATIONS WERE DOUBLE CHECKED AND EVERYTHING WAS NORMAL ON THAT END. THE LINER SEEMED TO NOT BE FITTING THE HEAD CORRECTLY AND LIKE THERE WAS MORE SPACE THAN USUAL. I CALLED MY MANAGER AND SHARED A VIDEO TO CONFIRM IF HE KNEW IF THIS WAS NORMAL AND HE DOUBLE CHECKED WITH ANOTHER SURGEON. NEITHER COULD CONFIRM IF THE IMPLANTS WERE OKAY OR NOT SO WE DECIDED TO REMOVE THEM AND OPEN A NEW HEAD AND LINER. THE SURGEON DID NOT THINK THE NEW HEAD AND LINER WERE PREFORMING STRANGELY LIKE THE PREVIOUS ONES WERE SO WE COMPLETED THE CASE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 5, ACTION TAKEN WHEN EVENT OCCURRED? BOTH IMPLANTS WERE REMOVED AND NEW ONES WERE OPENED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552372 ↗
• InjuryJan 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HIP WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18440931 ↗
• InjuryJan 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD LUXATION OF THE HIP AND UNDERWENT A CHANGE OF HEAD TO BIGGER SIZE.

  Patient problems: Joint Dislocation

  MAUDE report 18440824 ↗
• InjuryJan 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LUXATION BI LATERAL BY PLAYING GOLF GYROS LINER HEAD (B)(4) ARE RELATABLE TO CAPTURE THE BILATERAL LUXATION. AS IT WAS NOT CONFIRMED WHICH PRODUCTS WERE USED ON WHICH SIDE, FOLLOW UP WAS INITIATED TO CONFIRM THAT. FOR NOW, IT WAS ASSUMED THAT (B)(4) CAPTURE THE LEFT HIP AND (B)(4) CAPTURE THE RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18433985 ↗
• InjuryJan 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LUXATION BI LATERAL BY PLAYING GOLF GYROS LINER HEAD (B)(4) ARE RELATABLE TO CAPTURE THE BILATERAL LUXATION. AS IT WAS NOT CONFIRMED WHICH PRODUCTS WERE USED ON WHICH SIDE, FOLLOW UP WAS INITIATED TO CONFIRM THAT. FOR NOW, IT WAS ASSUMED THAT (B)(4) CAPTURE THE LEFT HIP AND (B)(4) CAPTURE THE RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18433968 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT RETURNED TO SURGERY FOR INFECTION S/P HIP HEMI. ALL OF THE IMPLANTS WERE REMOVED AND THE WOUND WAS DEBRIDED AND IRRIGATED. NEW IMPLANTS WERE PLACED. THERE WERE NO DEFICIENCIES, DELAYS OR BROKEN INSTRUMENTS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18364031 ↗