BIOLOX DELTA OPTION HIP SYSTEM 650-1055Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304521919), received between Jun 13, 2019 and May 27, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K082996); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME INFECTED POST LEFT HIP REVISION THAT REQUIRED A SECONDARY REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 14520698 ↗
• InjuryApr 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION APPROXIMATELY 1 YEAR POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 13993688 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT THA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED SEVERAL TIMES. THE PATIENTS' LEGAL ATTORNEY CLAIMS THAT THE PATIENT CONTINUES TO SUFFER FROM PAIN, LOST MOBILITY AND A LEG LENGTH DISCREPANCY AS A RESULT OF THE REVISION SURGERY ON (B)(6) 2019.

  Patient problems: Ambulation or Postural Difficulties; Pain; Unequal Limb Length

  MAUDE report 12031543 ↗
• InjuryJun 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. THE ACTIVE ARTICULATION BEARING AND CERAMIC HEAD WERE REMOVED AND REPLACED.

  Patient problems: Joint Dislocation

  MAUDE report 10200131 ↗
• InjuryNov 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO METAL ON METAL COMPLICATIONS. UPON DISCHARGE FROM THE HOSPITAL, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS, WOUND DRAINAGE WITH DEHISCENCE, AND FEVERS. THE PATIENT WAS AGAIN REVISED DURING WHICH A BLOOD LOSS, PSEUDOTUMOR, HEMATOMA, OSTEOLYSIS, AND TISSUE DAMAGE WAS NOTED WITH POSITIVE FROZEN SECTIONS, INFECTION, WOUND COMPLICATIONS, AND PAIN. IMPLANT WEAR WAS ALSO NOTED DUE DISASSOCIATION OF THE ACTIVE ARTICULATION SYSTEM. THE ACETABULAR SHELL, HEAD, AND LINER WERE REPLACED, AND THE PATIENT WAS PLACED ON PROLONGED IV ANTIBIOTICS.

  Patient problems: Fever; Joint Dislocation; Pain; Wound Dehiscence

  MAUDE report 9321491 ↗
• InjuryAug 2, 2019Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION DUE TO PAIN AND METAL ON METAL COMPLICATIONS. DURING THE REVISION, IT WAS NOTED THAT THE METAL HEAD WOULD NOT DISENGAGE/RELEASE FROM THE TRUNNION DURING EXPLANTATION, EXTENDING THE SURGICAL TIME BY AN HOUR BEFORE THE HEAD AND TRUNNION WERE SEPARATED. THE PATIENT WAS REVISED AGAIN. INTRAOPERATIVELY IT WAS IDENTIFIED THE PATIENT HAD A LARGE PSEUDOTUMOR, OSTEOLYSIS AROUND THE ACETABULUM AND FEMORAL CALCAR REGION, BONE AND TISSUE DAMAGE. CORROSION WAS NOTED AT THE FEMORAL HEAD/ADAPTER INTERFACE. THE ACETABULAR SHELL AND FEMORAL STEM WERE RETAINED AND ALL OTHER DEVICES WERE REVISED.

  Patient problems: Fever; Joint Dislocation; Pain

  MAUDE report 8854407 ↗
• InjuryJun 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT HIP REPLACEMENT SURGERY. SUBSEQUENTLY, AN INCISION AND DRAINAGE PROCEDURE WAS PERFORMED DUE TO DELAYED WOUND HEALING, AND WHERE ALSO AN OLD HEMATOMA WAS ENCOUNTERED. THE WOUND WAS DEBRIDED AND IRRIGATED WITHOUT SIGNS OF INFECTION NOTED.

  Patient problems: Hematoma

  MAUDE report 8694893 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082996. One submission often covers many models, so check the product and lot details in each record.

• Z-3133-2024 · Aug 8, 2024 · Open, Classified
  Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1
• Z-3132-2024 · Aug 8, 2024 · Open, Classified
  Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 6
• Z-0302-2018 · Jun 5, 2017 · Terminated
  CER BIOLOXD OPTION HD 32MM, model # 650-1056
• Z-0301-2018 · Jun 5, 2017 · Terminated
  CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064