Biolox® delta 00-8775-036-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00889024430365), received between Nov 2, 2018 and Sep 10, 2026 — classified as 68 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 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 69 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Bursitis; Fall; Pain

  MAUDE report 50723278 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bursitis; Fall; Pain

  MAUDE report 50722920 ↗
• InjuryJun 3, 2026Device Dislodged or Dislocated

  INITIAL LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE IN 2024. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO SUSPICION OF INLAY FRACTURE. DURING THE REVISION SIGNIFICANT METALLOSIS WAS NOTED. THE INLAY WAS FOUND DISLOCATED FROM THE BENEATH THE CERAMIC HEAD AND WAS POSITIONED MEDIAL-CAUDALLY. THE STEM AND CUP WERE RETAINED, WHILE THE INLAY AND HEAD WERE REVISED. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Crepitus; Joint Dislocation; Metal Related Pathology; Pain

  MAUDE report 25374001 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Impaired Healing

  MAUDE report 24597627 ↗
• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Pain; Unequal Limb Length

  MAUDE report 23669820 ↗
• InjuryNov 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP REPLACEMENT. SUBSEQUENTLY, APPROXIMATELY 1 MONTH AND A WEEK POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO DISLOCATION. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 23465145 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT THA. SUBSEQUENTLY, APPROXIMATELY 11 YEARS AND 4 MONTHS POST IMPLANTATION, DEVELOPED MILD RIGHT HIP PAIN WHICH HAS REQUIRED ILIOPSOAS INJECTION. SYMPTOMS HAVE REPORTEDLY RESOLVED AT THIS TIME. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 23358655 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED . SUBSEQUENTLY, AT THE 2 YEAR VISIT, THE PATIENT REPORTED SNAPPING IN THE HIP. CLINIC NOTES INDICATE THAT THE PATIENT IS EXPERIENCING ILIOPSOAS TENDINITIS WHICH OCCURS WHEN THE PATIENT¿S HIP IS IN AN EXTREME ROTATED POSITION FROM POSSIBLE CUP OR LINER IMPINGEMENT. PATIENT WAS INSTRUCTED TO AVOID EXTREME POSITIONS. PATIENT WAS REFERRED FOR AN INJECTION UNDER FLUOROSCOPY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Impingement; Pain; Tendinopathy

  MAUDE report 22887417 ↗
• InjuryJun 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, 38 DAYS POST IMPLANTATION, WAS REVISED DUE TO PAIN AND DISLOCATION. THE SHELL, HEAD, AND NECK WERE EXCHANGED WITHOUT COMPLICATIONS. THE STEM REMAINED IMPLANTED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Hematoma; Joint Dislocation; Pain

  MAUDE report 22337791 ↗
• InjuryJun 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY 2 YEARS AND 4 MONTHS POST IMPLANTATION, WAS REVISED DUE TO PAIN, INSTABILITY, SUBLUXATION, AND DISLOCATION. DURING THE REVISION, IT WAS NOTED THE POLYETHYLENE WAS FRACTURED. THE HEAD, NECK AND LINER WERE EXCHANGED WITHOUT COMPLICATIONS. THE STEM AND SHELL REMAINED IMPLANTED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

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

  MAUDE report 22336344 ↗
• InjuryJun 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A RT THA REVISION APPROXIMATELY 6 YEARS POST-IMPLANTATION DUE TO RECURRENT DISLOCATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Hematoma; Joint Dislocation; Pain

  MAUDE report 22237819 ↗
• InjuryApr 28, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, APPROXIMATELY 6 YEARS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO LINER FRACTURE, WEAR, AND METALLOSIS. DURING THE REVISION, THE HEAD AND CUP WERE FOUND TO BE WORN, AND THE LINER WAS FRACTURED. THE ACETABULAR COMPONENTS AND HEAD CONSTRUCT WERE EXCHANGED WITHOUT COMPLICATION AND THE INITIAL STEM WAS RETAINED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 21919347 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY AND, SUBSEQUENTLY REPORTED PAIN, POPPING AND GRINDING NOISE WHEN WALKING, AND DIFFICULTY WITH MOVEMENT. CT AS WELL AS EXAM NOTED LEG LENGTH DISCREPANCY. APPROXIMATELY 1.5 YEARS POST-IMPLANTATION, THE PATIENT HAD A RIGHT TOTAL HIP REVISION. DURING THE REVISION, THICK CAPSULE WITH POSTERIOR IMPINGEMENT OF THE TROCHANTER ON THE PELVIS WAS NOTED AS WELL AS A SLIGHTLY RETROVERTED ACETABULAR CUP. TRUNNION WAS FOUND TO BE CLEAN WITHOUT SIGNIFICANT DAMAGE. THE CUP, LINER, AND HEAD WERE REVISED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

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

  MAUDE report 21740386 ↗
• InjuryFeb 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 4 YEARS AND 3 MONTHS POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 21421586 ↗
• InjuryJan 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Pain

  MAUDE report 21278384 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN, SWELLING, BURNING SENSATION AND HAS A NICKEL ALLERGY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 21265053 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Bursitis; Pain; Unequal Limb Length

  MAUDE report 20855744 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Bursitis; Pain

  MAUDE report 20824059 ↗
• InjurySep 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: Insufficient Information

  MAUDE report 20169979 ↗
• InjurySep 5, 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: Abscess; Medical device site infection

  MAUDE report 20145924 ↗
• InjuryMar 19, 2024Biocompatibility; Biocompatibility

  UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18928756 ↗
• InjuryMar 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED APPROXIMATELY ONE YEAR AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATIONS. DURING THE REVISION, IT WAS NOTED THAT THE PATIENT¿S INITIAL CAPSULAR REPAIR WAS COMPLETELY TORN ON THE POSTERIOR CAPSULE WHICH HAD SCARRED DOWN POSTERIORLY CAUSING DISLOCATIONS. THE SCAR TISSUE WAS REMOVED WHICH INCREASED STABLE RANGE OF MOTION. THE HEAD, NECK, AND LINER WERE REPLACED WITH A CONSTRAINED SYSTEM WHICH FURTHER ENHANCED STABLE RANGE OF MOTION. THE INITIAL CUP AND STEM WERE LEFT INTACT, AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DILIGENCE IS COMPLETE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation; Muscle/Tendon Damage; Scar Tissue

  MAUDE report 18828318 ↗
• InjuryDec 18, 2023Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION PROCEDURE 6 YEARS AND 9 MONTHS POST IMPLANTATION DUE TO THE LINER FRACTURING AT THE LOCKING RING. THERE WAS METAL TRANSFER ONTO THE CERAMIC FEMORAL HEAD AND EVIDENCE THAT THE HEAD HAD BEEN RUBBING ON THE INTERIOR OF THE ACETABULAR SHELL. AMBULATION WAS LIMITED BY PAIN. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18343507 ↗
• InjuryOct 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Failure of Implant

  MAUDE report 17928932 ↗
• InjurySep 26, 2023Material Erosion; Material Erosion

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 17816371 ↗