BIOLOX DELTA 1365-36-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 839 adverse event reports that list this exact device (DI 10603295033615), received between May 8, 2014 and Sep 18, 2026 — classified as 821 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (251 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 839 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50828123 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to removal of liner, head, and screw due to infection.DOI: Unknown,DOR:(b)(6) 2026,Affected Side: Left Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50825494 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50825406 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50806649 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented acutely at ED on 17/8/26 unable to weight-bear on right side 10 years post THA following a deep flexion movement (no fall). The patient was taken to theatre on 19/8/26 and revision of liner and head was performed. A 56 x 36 lipped ALTRX liner was implanted and a 1.5mm Delta TS head. The surgeon was confident there was no damage to inner surface of cup insitu and decided to leave in place.

  Patient problems: Loss of Range of Motion

  MAUDE report 50713335 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Deformity/ Disfigurement; Joint Laxity; Loss of Range of Motion; Pain; Synovitis

  MAUDE report 50677911 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to prostalac placement for infection. There was a removal of all implants.DOI: (b)(6) 2024DOR: (b)(6), 2026Affected side: Left

  Patient problems: Unspecified Infection

  MAUDE report 50530845 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50522233 ↗
• InjuryAug 27, 2026Device Dislodged or Dislocated

  It was reported that patient was revised due to dislocation.Affected side: Left hip

  Patient problems: Joint Dislocation

  MAUDE report 50478451 ↗
• InjuryAug 5, 2026Device Dislodged or Dislocated

  It was reported that the patient had surgery. The only available information was the size head that was removed. The patient was a chronic dislocator and the numbers on the head were worn away. This was a ceramic 36 + 1.5 head, chronic dislocator and members were worn off.Affected side-Right hip.

  Patient problems: Joint Dislocation

  MAUDE report 50139413 ↗
• InjuryJul 30, 2026Device Dislodged or Dislocated

  It was reported that the patient dislocated. The cup became unstable post dislocation and had to be revised.DOI: (b)(6) 2026,DOR: (b)(6) 2026,Affected side: Left Hip.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 50086274 ↗
• InjuryJul 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS DISLOCATING SO WE WENT TO DUAL MOBILITY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25733233 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION OF LEFT THA BOTH FEMORAL HEAD AND ACETABULAR LINER DUE TO COMPLAINTS OF PERSISTENT LEFT HIP PAIN. DURING THE PROCEDURE THE ACETABULAR LINER WAS GROSSLY LOOSE AND WAS REMOVED WITH A HAND TOOL. SAUCERIZATION OF LEFT LATERAL FEMORAL CORTEX. TRANSFER OF GLUTEUS MAXIMUS AND TENSOR FASCIA LATA TO GREATER TROCHANTER. PLACEMENT OF SURGEON PREPARED ANTIBIOTIC LOADED BIODEGRADABLE BEADS. DOI: (B)(6), 2019 DOR: (B)(6) 2024 AFFECTED AREA: LEFT HIP.

  Patient problems: Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 25691867 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 25518925 ↗
• InjuryJun 12, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. CONVERTED TO DM. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25490180 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 25471518 ↗
• InjuryJun 2, 2026Naturally Worn

  LINER BREAKAGE POST-OP. THE PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2026, DUE TO FEMORAL HEAD NECROSIS. DELTA CERAMIC HEAD AND CERAMIC LINER WERE IMPLANTED. THE HOSPITAL REPORTED THAT THE SURGICAL PROCESS AND POSTOPERATIVE REHABILITATION TREATMENT WERE SMOOTH. THREE MONTHS AFTER SURGERY (B)(6) 2026), THE PATIENT SOUGHT MEDICAL ATTENTION DUE TO SELF PERCEIVED DISCOMFORT AND REPORTED NO HISTORY OF FALL, IMPACT, OR STRENUOUS EXERCISE. X-RAY EXAMINATION REVEALED THAT THE CERAMIC LINER WAS BROKEN. THE DOCTOR PERFORMED A SECOND SURGERY ON THE PATIENT AND REMOVED THE BROKEN LINER. SINCE THE CERAMIC HEAD WAS WORN BY THE FRAGMENT, THE CERAMIC HEAD WAS REMOVED TOGETHER. THE PATIENT IS CURRENTLY IN A STABLE CONDITION AND NO SUBSEQUENT ADVERSE EVENT REPORTS HAVE BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 25365419 ↗
• InjuryJun 1, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD DISLOCATED. THE DOCTOR EXPLANTED THE HEAD AND LINER AND REPLACED THEM WITH A LONGER HEAD AND LATERALIZED LINER. DOI: (B)(6) 2024. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25348551 ↗
• MalfunctionMay 14, 2026Difficult to Insert

  IT WAS REPORTED THAT A RECLAIM MONOBLOCK WAS PLACED DUE TO A FRACTURE IN THE FEMUR. A 36+1.5 CERAMIC HEAD WAS OPENED. THE DOCTOR CLEANED THE TREPHINE BEFORE PLACING THE HEAD. THE REPORTER WAS UNABLE TO OBSERVE IMPACT OR TESTING OF THE HEAD BEFORE RELOCATION. AFTER RELOCATION THE PATIENT'S LEG LENGTH WAS TOO LONG, SO THE HEAD WAS DISLOCATED. ONCE DISLOCATED THE HEAD WAS LOOSE. A NEW HEAD WAS OPENED AND WAS SECURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. DOE: (B)(6) 2026. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 25174840 ↗
• InjuryMay 12, 2026Device Dislodged or Dislocated

  IT REPORTED THAT PT DISLOCATED NO ADDITIONAL INFO NO DELAY NOTHING WRONG WITH PRODUCTS. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 25148537 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION ASSOCIATED WITH PROSTALAC. DOI-UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE-LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25086568 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY LINER AND CERAMIC HEAD WERE EXPLANTED DUE TO SHORT LEG LENGTH. NEW POLY LINER WAS IMPLANTED WITH LONGER HEAD. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 25086011 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TOTAL HIP WAS UNSTABLE. CONVERTED TO DUAL MOBILITY AND LONGER HEAD. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25055244 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL WASH OUT. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE-RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 25035832 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH HIP INSTABILITY AND REQUIRING A BEARING AND HEAD EXCHANGE. DOI: (B)(6) 2023, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25035315 ↗