BIOLOX® Delta Hip System 12-115117Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868248467), received between Aug 20, 2021 and Aug 20, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K042091, K051411); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2021Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A CUSTOM HIP IS NEEDED FOR POSSIBLE REVISION DUE TO LIMB LENGTH DISCREPANCIES AND PATIENT ANATOMY. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Necrosis; Pain; Swelling/ Edema; Unequal Limb Length

  MAUDE report 12346760 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042091, K051411. One submission often covers many models, so check the product and lot details in each record.

• Z-2145-2020 · Apr 17, 2020 · Terminated
  Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105
• Z-1613-2009 · Mar 16, 2009 · Terminated
  Biomet Biolox-Delta Modular Ceramic Head, 28 mm head diameter, plus 5 neck, type 1, taper, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Catalog Number 12-115112. A hip joint met
• Z-1614-2009 · Mar 16, 2009 · Terminated
  Biomet Modular TTPA Ceramic Head, 28 mm head diameter plus 5 mm neck, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Catalog Number: RD115112. A hip joint metal/ceramic/polymer s