BIOLOX® delta Option 650-1057Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00887868271397), received between Apr 8, 2020 and Aug 10, 2026 — classified as 23 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient reported ongoing extreme pain and swelling after the revision. Attempts have been made, and no further information has been provided.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 50190642 ↗
• InjuryMar 2, 2026Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 24481793 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20545048 ↗
• InjurySep 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY THREE YEARS LATER DUE TO RECURRENT DISLOCATIONS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 20118003 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY NEARLY TWO YEARS AGO AND SUBSEQUENTLY, APPROXIMATELY TWO WEEKS LATER, DEVELOPED ERYTHEMA AT THE MEDIAL ASPECT OF THE LEFT HIP INCISION AND WAS PRESCRIBED ORAL MEDICATION FOR TWO WEEKS AND WAS RESOLVED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Impaired Healing

  MAUDE report 18911428 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 18873287 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY LEGAL ALLEGATIONS THAT A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY SIXTEEN YEARS AGO FOLLOWED BY A REVISION ABOUT SEVEN YEARS POST IMPLANTATION DUE METAL RELATED PATHOLOGY. SUBSEQUENTLY, THE PATIENT HAD A CHRONIC TROCHANTERIC AVULSION FRACTURE AND DEVELOPED PAIN, STIFFNESS, RANGE OF MOTION ISSUES, AND A FALL THAT LED TO ONGOING DIAGNOSTIC TESTS WITH SUSPICION OF ALVAL. APPROXIMATELY TWO YEARS AGO, THE PATIENT UNDERWENT A STAGE I REVISION FOR INFECTION. DURING THE PROCEDURE, A SMALL FRACTURE OF THE ANTERIOR CORTEX OCCURRED FROM THE WEDGING OF THE OSTEOTOME, THE PATIENT EXPERIENCED BLOOD LOSS, ALL IMPLANTS WERE REMOVED, AND A COMPETITOR CEMENT SPACER WAS IMPLANTED. STAGE II REVISION FOLLOWED ONE AND A HALF MONTHS LATER WITH COMPETITOR PRODUCT IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bacterial Infection; Bone Fracture(s); Fall; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Loss of Range of Motion; Muscle/Tendon Damage; Osteolysis; Pain

  MAUDE report 18811063 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pulmonary Embolism

  MAUDE report 18516124 ↗
• MalfunctionJan 15, 2024Scratched Material; Scratched Material

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510109 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Bursitis; Pain

  MAUDE report 18474812 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT UNDERWENT A HIP ARTHROPLASTY SURGERY. SUBSEQUENTLY THE PATIENT IS BEING REVISED DUE TO A FALL AND POOR BONE QUALITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fall; Osteopenia/ Osteoporosis

  MAUDE report 18474452 ↗
• InjuryNov 16, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s); Insufficient Information; Joint Dislocation

  MAUDE report 18146716 ↗
• InjuryJun 28, 2023Material Erosion; Fracture; Material Erosion; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 17215615 ↗
• InjuryMay 30, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Metal Related Pathology; Pain

  MAUDE report 17017987 ↗
• InjuryMay 23, 2023Unstable; Unstable

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Fall

  MAUDE report 16983318 ↗
• InjuryApr 13, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 16731790 ↗
• InjuryOct 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO IMPLANT FRACTURE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 15595224 ↗
• InjuryMay 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED IN MEDICAL NOTES RECEIVED THAT PATIENT EXPERIENCED DISLOCATION APPROXIMATELY 5 MONTHS POST-IMPLANTATION. IT IS UNKNOWN IF MEDICAL INTERVENTION TOOK PLACE.

  Patient problems: Joint Dislocation

  MAUDE report 14369242 ↗
• InjuryApr 14, 2022Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT: A CERAMIC HEAD EXCHANGE FOR A COBALT CHROME HEAD (COCR). THE DOCTOR THINKS THE CERAMIC TAPER MAY HAVE DISENGAGED FROM THE TAPERLOC STEM AND IT COULD HAVE BEEN PISTONING. I WOULD LIKE TO HEAR BACK IF ANYTHING IS FOUND ABOUT THE IMPLANTS. PRIMARY SURGERY WAS DONE ON (B)(6) 2013. PATIENT OUTCOME: REVISION.

  Patient problems: Failure of Implant

  MAUDE report 14110805 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT: THE PATIENT UNDERWENT A SECOND REVISION IN 2017 FOR UNKNOWN REASONS. REOPENED THE COMPLAINT ON (B)(6) 2016 DUE TO ADDITIONAL INFORMATION RECEIVED BY LEGAL ON (B)(6) 2016. LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT WAS REVISED ON (B)(6) 2015, DUE TO PATIENT ALLEGATIONS OF PAIN, METAL DEBRIS, MIGRATED CUP, METALLOSIS, ELEVATED METAL ION LEVELS, NECROTIC TISSUE AND OSTEOLYSIS. THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED AND A POLYETHYLENE LINER WAS IMPLANTED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE OPERATIVE REPORT WAS THAT DURING THE REVISION PROCEDURE, THE HEAD TOOK APPROXIMATELY THIRTY MINUTES TO REMOVE. THE PRESENCE OF GREYISH BLACK MATERIAL, GREY FLUID WITH METAL DEBRIS, AND A LACK OF BONY INGROWTH/FIBROUS INGROWTH AROUND THE CUP WAS NOTED. THE PATIENT'S LEGAL COUNSEL REPORTED LAB RESULTS ON (B)(6) 2014, ALLEGEDLY REVEALING A COBALT SERUM LEVEL OF 196.1 MCG/L A

  Patient problems: Failure of Implant; Metal Related Pathology; Pain

  MAUDE report 14083911 ↗
• InjuryMar 8, 2022Activation, Positioning or Separation Problem; Activation Problem; Activation, Positioning or Separation Problem; Activation Problem

  IT WAS REPORTED, THAT: IN MEDICAL NOTES RECEIVED THE PATIENT UNDERWENT A CLOSED REDUCTION PROCEDURE APPROXIMATELY 7 MONTHS POST-IMPLANTATION DUE TO DISLOCATION. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND CLOSED REDUCTION PROCEDURE APPROXIMATELY 12 MONTHS POST-IMPLANTATION. THE PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY 14 MONTHS POST-IMPLANTATION DUE TO THE REOCCURRING DISLOCATION. DURING THE PROCEDURE, THE FEMORAL HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED. PATIENT INVOLVEMENT - REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 13692216 ↗
• MalfunctionNov 22, 2021Activation, Positioning or Separation Problem; Positioning Problem; Activation, Positioning or Separation Problem; Positioning Problem

  IT WAS REPORTED, THAT: THE PATIENT HAD THE RIGHT TOTAL HIP REPLACED APPROXIMATELY 25 YEARS AGO IN OREGON. ZIMMER 411 HELPED IDENTIFY LIKELY CUP STEMS MALLORY COMPONENTS. REVISION SURGERY WAS COMPLETED BY DR (B)(6) ON (B)(6) 2021 FOR OSTEOLYSIS AND PAIN IN THE RIGHT HIP. THE CUP AND STEM DID APPEAR TO BE MALLORY. CUP SAID 54 ON IT. THE HEAD WAS A 28 STD JUST SAID STD THAT WE COULD READ. NOTHING OFF THE LINER COULD BE READ. A RINGLOC REPLACEMENT LINER WAS USED SIZE 24. THE DOCTOR FIRST A TYPE ONE REVISION WITH CERAMIC HEAD (+6 SLEEVE AND 16/18 TAPER BIOLOX OPTION 36 HEAD). THE HEAD AND SLEEVE DID NOT APPEAR TO SIT DOWN AS FAR AS THE TRIAL HEAD. THE DOCTOR WAS HESITANT TO IMPACT AS THERE WAS CLOSE TO A 1CM GAP FROM THE END OF THE SLEEVE TO THE END OF THE STEM. THE DOCTOR THEN USED A +9 COCR TYPE ONE 36 HEAD AND IMPACTED. IT ALSO SEEMED TO SIT HIGH ON THE TRUNION. THE DOCTOR ASKED ME TO SEND THE SLEEVE AND NECK IN AND CONFIRM IT IS THE CORRECT SIZE FOR A TYPE ONE TAPER. PATIENT OUTCOME- REVISION.

  Patient problems: Osteolysis; Pain

  MAUDE report 12851478 ↗
• InjuryAug 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT AN INITIAL LEFT HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2012. SUBSEQUENTLY, REVISED ON (B)(6) 2018 DUE TO SPONTANEOUS PAIN WHILE WALKING WITH NOISE. DURING REVISION, IT WAS NOTED THAT THE POLY WAS FRACTURED, THE SHELL WAS COLD-WELDED AND THE CERAMIC HEAD WAS WEARING ON THE SHELL. THE POLY, LINER, AND HEAD WERE EXCHANGED.

  Patient problems: Failure of Implant; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12292536 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; No Information

  MAUDE report 11035800 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CLINICAL STUDY (B)(4) THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, AT THE TWO YEAR VISIT, THE PATIENT REPORTED INCREASED PAIN , STIFFNESS AND A DECREASE IN SATISFACTION. A BONE SCAN WAS PERFORMED AND MRI PLANNED. PATIENT OPTED OUT OF MRI.

  Patient problems: Pain

  MAUDE report 9937646 ↗