BIOLOX® delta Option 650-1058Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00887868271403), received between Apr 8, 2020 and Dec 22, 2025 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bradycardia; Hematoma; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 23872298 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION.

  Patient problems: Hematoma; Pain; Post Operative Wound Infection

  MAUDE report 23756438 ↗
• InjurySep 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation; Joint Impingement; Joint Laxity; Pain

  MAUDE report 23013655 ↗
• InjurySep 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 22936427 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL STUDY THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO SEVERE PAIN AND FAILED IMPLANTS. PATIENT EXPERIENCED PAIN, WEAKNESS, TROCHANTERIC BURSITIS, AND POSSIBLE ILIOPSOAS TENDINITIS. THE SHELL WAS RETAINED AND ALL OTHER IMPLANTS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bursitis; Failure of Implant; Inflammation; Muscle Weakness/Atrophy; Pain

  MAUDE report 22182226 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20786282 ↗
• InjuryMay 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 16893556 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED 23-DAYS POST-IMPLANTATION, DUE TO A SUPERFICIAL INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 15914596 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION DUE TO HEAD AND SLEEVE BEING LOST IN PATIENT BODY DURING INITIAL SURGERY. IT WAS CONCLUDED THAT PRODUCT MAY HAVE TRAVELED UP INTO THE ABDOMEN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15884337 ↗
• InjuryDec 9, 2021Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT: THE DOCTOR REPLACED A REGULAR LINER FOR A FREEDOM CONSTRAINED FOR DISLOCATING. PATIENT INVOLVEMENT- NO FURTHER OUTCOME.

  Patient problems: Joint Dislocation

  MAUDE report 12966859 ↗
• InjuryNov 18, 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 HIP PROCEDURE IN 2021. SUBSEQUENTLY, THE PATIENT STATES HE IS HAVING SEVERE PAIN, UNABLE TO WALK AND HAS ISSUES WITH THE HIP COLLAPSING AND HAS FALLEN SEVERAL TIMES. PATIENT STATED HE WAS HIT BY DRUNK DRIVER (B)(6) 2019 AND HAS NEEDED SEVERAL SURGERIES OVER HIS WHOLE BODY DUE TO THE ACCIDENT.

  Patient problems: Ambulation or Postural Difficulties; Fall; Pain

  MAUDE report 12834461 ↗
• InjuryNov 2, 2021Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THE PATIENT WAS REVISED DUE TO DISLOCATION AND INSTABILITY ON (B)(6) 2021. HEAD AND LINER REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 12736008 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT LEFT THA DUE TO FEMORAL NECK FRACTURE ON (B)(6) 2021. PATIENT WAS REVISED TWO DAYS LATER DUE TO AN IATROGENIC ACETABULAR FRACTURE. THE PATIENT UNDERWENT A SECOND REVISION ON (B)(6) 2021 DUE TO PAIN AND INSTABILITY WITH PLACEMENT OF A CUSTOM CAGE AND CONSTRAINED LINER. DURING THE REVISION, SIGNIFICANT SCARRING WAS NOTED WHICH PROMPTED THE REMOVAL OF THE FEMORAL COMPONENT. THE ACETABULAR COMPONENT WAS FOUND WELL FIXED AND INGROWN. THE CEMENTED LINER WAS REMOVED AS WELL AS THE CUP. BACKING OUT THE SCREWS WAS NOT POSSIBLE, SO THE SURGEON CUT THEM WITH A BUR SO THAT THE CUSTOM CAGE COULD BE PLACED. DUE TO INTRAOPERATIVE COMPLICATIONS (SEE NEW COMPLAINT), ONLY THE CUSTOM CAGE, LINER, AND SCREWS WERE PLACED. THE WOUND WAS CLOSED WITHOUT FEMORAL COMPONENTS IN PLACE, AND THE PATIENT WAS TRANSFERRED TO THE CRITICAL CARE UNIT.

  Patient problems: Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 12670791 ↗
• MalfunctionSep 1, 2021Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT DURING INITIAL SURGERY, THE SURGEON WAS UNABLE TO ACHIEVE FIXATION OF THE CERAMIC HEAD WHEN IMPACTING TO A TAPERLOC STEM. THE TAPER REMAINED BUT THE CERAMIC HEAD WOULD COME OFF. THE SURGERY WAS COMPLETED WITH A COBALT CHROME HEAD, SIZE 40 -6 WHICH IMPACTED WITH NO ISSUE. ATTEMPTS HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406032 ↗
• InjuryAug 27, 2021Loss of or Failure to Bond; Unintended Movement; Patient Device Interaction Problem; Loss of or Failure to Bond; Unintended Movement; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY WAS PERFORMED (B)(6) 2013. SUBSEQUENTLY, THE PATIENT WAS REVISED (B)(6) 2019 DUE TO METAL RELATED PATHOLOGY. A FEW MONTHS LATER, THE PATIENT DEVELOPED INSTABILITY WITH RECURRENT DISLOCATIONS. A SMALL NONDISPLACED TRANSVERSE ACETABULAR FRACTURE WAS IDENTIFIED ON X-RAY. THE PATIENT UNDERWENT A SECOND REVISION ON (B)(6) 2020. DURING THE REVISION, IMPINGEMENT WAS NOTED AS WELL AS DISRUPTION OF THE PREVIOUS CAPSULAR REPAIR. THE INITIAL STEM AND REVISION SHELL WERE LEFT INTACT. THE HEAD AND LINER WERE REPLACED WITHOUT COMPLICATION.

  Patient problems: Bone Fracture(s); Failure of Implant; Joint Dislocation; Muscle/Tendon Damage

  MAUDE report 12376254 ↗
• InjuryApr 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATIONS.

  Patient problems: Joint Dislocation

  MAUDE report 11724002 ↗
• InjuryApr 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED AN ANTERIOR DISLOCATION IN POSTOP RECOVERY ROOM. MANIPULATION UNDER SEDATION WAS PREFORMED, THEN X-RAYS REVEALED AN UNSTABLE HIP SO THE PATIENT WAS BROUGHT BACK TO THE OR FOR A REVISION SURGERY. THE STEM, HEAD AND LINER WERE REMOVED AND REPLACED.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 9937447 ↗