BIOLOX DELTA 1365-32-330Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 10603295033455), received between Jun 23, 2017 and Apr 30, 2026 — classified as 1 death, 123 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (56 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 131 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED. HEADBALL POLY EXCHANGE WAS PERFORMED. THERE WAS NO DELAY. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25043622 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS REVISED DUE TO UNSTABLE HIP. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24862709 ↗
• InjuryJan 22, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATING. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24146013 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR BROUGHT THE PATIENT TO THE OR FOR HEAD AND POLY EXCHANGE. CULTURES WERE TAKEN TO DISCOVER IF INFECTION WAS PRESENT, UNKNOWN DATE OF IMPLANT, NO ADDITIONAL INFORMATION PROVIDED FOR REPORTING. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23717027 ↗
• InjuryNov 25, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PINNACLE LINER LUXATION OUT OF THE PINNACLE CUP; ONE PIECE HAS BROKEN OFF. THE HEAD HAD BEEN ARTICULATING AGAINST THE CUP FLOOR AND NOW SHOWS SIGNS OF WEAR.

  Patient problems: Insufficient Information

  MAUDE report 23649285 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION OF HEAD AND LINER FOR INSTABILITY. LOOKS NORMAL ON XRAY. SPINAL FUSION. NO IMPLANT FAILURE. NO DELAY. NO OTHER INFORMATION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23413709 ↗
• InjuryOct 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A THA SURGERY FOR CERVICAL FRACTURE ON THE RIGHT HIP JOINT. AFTER THE SURGERY, THE SALES REPRESENTATIVE WAS INFORMED BY THE SURGEON THAT THE PATIENT DISLOCATED ON (B)(6) 2025. A NON-SURGICAL REDUCTION WAS PERFORMED ON THE SAME DAY THE DISLOCATION OCCURRED, BUT THE DISLOCATION OCCURRED AGAIN ON (B)(6) 2025. THE CAUSE OF BOTH DISLOCATIONS WAS A FALL WHILE IN A DELIRIOUS STATE DUE TO DEMENTIA. A SECOND NON-SURGICAL REDUCTION WAS PERFORMED, AND THE PATIENT IS CURRENTLY UNDER OBSERVATION. THERE WERE NO PROBLEMS WITH THE IMPLANT PLACEMENT OR ALIGNMENT, AND THE SURGEON HAS NOT MENTIONED ANY ISSUES WITH THE IMPLANT.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 23360820 ↗
• InjuryOct 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A THA SURGERY FOR CERVICAL FRACTURE ON THE RIGHT HIP JOINT WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, THE SALES REP WAS INFORMED BY THE SURGEON THAT THE PATIENT DISLOCATED ON (B)(6) 2025. A NON-SURGICAL REDUCTION WAS PERFORMED ON THE SAME DAY THE DISLOCATION OCCURRED. THE CAUSE OF DISLOCATION WAS A FALL WHILE IN A DELIRIOUS STATE DUE TO DEMENTIA. THERE WERE NO PROBLEMS WITH THE IMPLANT PLACEMENT OR ALIGNMENT, AND THE SURGEON HAS NOT MENTIONED ANY ISSUES WITH THE IMPLANT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 23357937 ↗
• InjurySep 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING ANTERIOR. THE SURGEON REMOVED THE HEAD AND POLY THEN TRIALED THE +4 10DEG PINNACLE POLY TRIAL WITH THE LIP ANTERIOR. RANGE OF MOTION WAS PERFORMED TO MAKE SURE THERE WAS NO IMPINGEMENT AND HIP WAS STABLE. THE SURGEON WAS HAPPY AND IMPLANTED NEW POLY LINER AND FEMORAL HEAD. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22955892 ↗
• InjuryAug 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT SHOWED DISLOCATION OF THE HIP THAT HAD JUST BEEN DONE IN POST OP. THE PATIENT WAS BROUGHT BACK TO THE OR TO FIX THE DISLOCATION. STEM AND HEAD COMPONENT WERE EXPLANTED AND BIGGER STEM AND SAME SIZE HEAD WERE REIMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 22903652 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY AND WENT UP A HEAD LENGTH. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 22714899 ↗
• MalfunctionJul 22, 2025Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: A. DID THE INSTRUMENT BROKE INTO 2 OR MORE PIECES? IF YES, WERE ALL THE FRAGMENT REMOVED? IN TWO PIECES, BUT ALL FRAGMENTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569779 ↗
• InjuryJul 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED 8 TIMES, AND THE SURGEON SWITCHED OUT THE LINER AND HEAD. THIS WAS THE FIRST REVISION SURGERY. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22470168 ↗
• InjuryJul 1, 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 INFECTED LEFT HIP. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22375666 ↗
• InjuryMay 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HEAD BALL AND POLYETHYLENE EXCHANGE DUE TO DISLOCATION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22107893 ↗
• InjuryJan 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR RECURRENT DISLOCATIONS FOLLOWING INITIAL SURGERY. DOI: UNKNOWN AND DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21197079 ↗
• InjuryJan 10, 2025Noise, Audible; Noise, Audible

  LITIGATION RECORDS RECEIVED. PATIENT ALLEGES MALFUNCTIONING, FAILURE, MECHANICAL LOOSENING OF THE INTERNAL PROSTHETIC JOINT, SQUEAKING SOUNDS, HIP PAIN , CLICKING, IMBALANCE, DIFFICULTY WALKING. IT BAND CORROSION AND FOUND A POLYETHYLENE FAILURE DUE TO A FRACTURE OF THE LOCKING MECHANISM. ECCENTRIC SUPERIOR POSITION OF THE FEMORAL HEAD RELATIVE TO THE ACETABULUM IS CONSISTENT WITH POLYETHYLENE WEAR. CALCIFIED UTERINE FIBROID. CONSISTENT WITH POSTERIOR IMPINGEMENT TRUNNION INTACT WITH A FEW MINOR SCRATCHES. WAS FOUND TO HAVE A DISSOCIATED ACETABULAR LINER. FEMORAL COMPONENT SHOWED SIGNIFICANT STRIPE WEAR. BLACK FILM TO THE ANTERIOR ASPECT, POSTERIOR CAPSULE AND SOME OF THE ABDUCTOR MUSCULATURE. DOI: (B)(6) 2021. DOR: (B)(6) 2023. RIGHT HIP. ON (B)(6) 2021 THE PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. DEPUY PRODUCTS WERE IMPLANTED DURING THIS SURGERY. (B)(6) 2023 RADIOGRAPHS NOTE THE PATIENT WAS STATUS POST RIGHT TOTAL HIP ARTHROPLASTY WITH THE INDICATIONS FOR RIGHT HIP JOINT PAIN. ECCENTRIC SUPERIOR POSITION OF THE FEMORAL HEAD RELATIVE TO THE ACETABULUM IS CONSISTENT WITH POLYETHYLENE WEAR. (B)(6) 2023, MEDICAL RECORDS NOTE THE PATIENT HAS CATASTROPHIC F

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 21125098 ↗
• InjuryOct 25, 2024Naturally Worn; Naturally Worn

  LINER BREAKAGE POST-OP AND HEAD WEAR. IT WAS REPORTED THE PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2023. THE PATIENT FELT LEFT HIP PAIN ON (B)(6) 2024 AND CT CHECK SHOWED LINER BREAKAGE AND HEAD WEAR. THEN, THE SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2024, THE LINER AND HEAD WERE REPLACED BY THE PRODUCT WITH SAME CODE. THE PATIENT IS IN A GOOD CONDITION NOW.

  Patient problems: Pain

  MAUDE report 20533640 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT LEFT HIP WAS REVISED ON (B)(6) 2024 DUE TO INFECTION. SURGEON REMOVED HEAD AND LINER AND REPLACED WITH NEW. DATE OF IMPLANT WAS (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 20446570 ↗
• InjuryOct 11, 2024Fracture; Fracture

  IT WAS ALLEGED THAT THE CERAMIC HEAD WAS BROKEN ON (B)(6) 2021. DOI: (B)(6) 2020. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20426889 ↗
• MalfunctionJul 8, 2024Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PACKAGE CAME WET AND OPEN. CONTENTS INSIDE WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19688835 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CALL RECEIVED FROM PATIENT TO RECEPTION: PATIENT'S LEFT HIP WAS SUCCESSFULLY REPLACED IN (B)(6) 2023 THEN HER RIGHT HIP WAS REPLACED (B)(6) 2023. LATER FOUND THE LINER DISLODGED CAUSING WEAR ON TITANIUM CUP AND INSTABILITY. PATIENT VISITED SURGEON ON TUESDAY (B)(6) 2024 AND SURGERY WAS PERFORMED ON WEDNESDAY (B)(6) 2024 TO REPLACE THE LINER AND CERAMIC HEAD.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19249558 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO THE CRACKING AND LOOSENING OF THE LINER SEEMINGLY DUE TO IMPINGEMENT OF TRUNNION ON SHELL/LINER. THE FOLLOWING IMPLANTS WERE EXPLANTED. NO REPLACEMENTS WERE NEEDED. NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18873828 ↗
• InjuryFeb 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A TOTAL HIP IMPLANTED, IN RECOVERY/PACU THE PATIENT DISLOCATED. THE PATIENT WAS BROUGHT BACK SAME DAY AND REVISED. FEMORAL HEAD AND STEM WERE REMOVED TO GAIN ACCESS TO LINER. LINER WAS CHANGED , STEM AND HEAD WERE ALSO EXCHANGED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18790432 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AUG 02, 2023 GYNECOLOGICAL MEDICAL RECORDS REPORTED RIGHT HIP SURGERY INDUCED BLOOD CLOT IN 2019. THERE WAS NO SPECIFICS PROVIDED. THERE WAS NO MENTION OF ANY INTERVENTIONS

  Patient problems: Hematoma

  MAUDE report 18525270 ↗