BIOLOX® Delta Hip System 12-115122Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887868248498), received between May 26, 2020 and Jun 12, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  IT WAS REPORTED THAT APPROXIMATELY 4 YEARS POST IMPLANTATION OF LEFT HIP ARTHROPLASTY, THE PATIENT EXPERIENCED A WORK RELATED FALL AND SUFFERED A CLAVICLE FRACTURE AS A RESULT OF THE FALL. AFTER THE FALL, THE PATIENT BEGAN EXPERIENCING SQUEAKING DURING AMBULATION, ALONG WITH SLIGHT DISCOMFORT. THE PATIENT WAS SUBSEQUENTLY REVISED. DURING THE REVISION, IT WAS NOTED THAT THE FEMORAL HEAD WAS WEARING AGAINST THE SHELL. THE HEAD AND LINER WERE EXCHANGED, WITH THE SURGEON EXCHANGING THE LINER FROM A SIZE 36 TO 40. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 17105637 ↗
• InjurySep 1, 2020Labelling, Instructions for Use or Training Problem; Use of Device Problem; Device Markings/Labelling Problem; Device Handling Problem; Labelling, Instructions for Use or Training Problem; Use of Device Problem; Device Markings/Labelling Problem; Device Handling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY. (B)(6) SHOWED IMPLANT BOXES TO DR.(B)(6) BEFORE IMPLANTS WERE OPEN ON THE BACK STERILE TABLE. AT THAT TIME, DR. (B)(6) APPROVED THE IMPLANTS TO BE OPENED. IT WAS NOTED THAT THE MAJORITY OF THE IMPLANT BOXES HAVE A LARGE FONT DESCRIPTION MAKING IT EASILY READABLE. HOWEVER, THE FEMORAL HEAD CONTAINS ONLY A SMALL FONT WITH 36MM ON THE BOTTOM OF THE LABEL. DR. (B)(6) SAW THE +3MM IN ORANGE BIOLOX DELTA HIP SYSTEM, AND ASSUMED EVERYTHING WAS COHESIVE. SUBSEQUENTLY A REVISION SURGERY TOOK PLACE ON (B)(6) 2020 AS IT WAS IDENTIFIED THAT THE INCORRECT SIZE DEVICE HAD BEEN USED DURING THE INITIAL SURGERY. THIS COMPLAINT REPORTS THE INCORRECT SIZE PRODUCT IMPLANTED IN THE PATIENT DURING INITIAL SURGERY ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10475789 ↗
• InjuryMay 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT THA ON MARCH 9, 2020 BY (B)(6). SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION AND WOUND DEHISCENCE ON MARCH 29, 2020 BY (B)(6).

  Patient problems: Joint Dislocation; Wound Dehiscence

  MAUDE report 10086150 ↗