BIOLOX® Delta Hip System 12-115114Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868248436), received between Sep 1, 2021 and Sep 1, 2021 — classified as 1 injury.

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.

• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED ON (B)(6) 2021. ONE WEEK POSTOP, THE PATIENT DEVELOPED PNEUMONIA AND WAS HOSPITALIZED FOR ONE WEEK. TWO WEEKS LATER, THE PATIENT DEVELOPED A DVT AND WAS TREATED IN THE HOSPITAL OVERNIGHT. BY THE ONE MONTH VISIT, THE PATIENT REPORTED HIGH SATISFACTION WITH ONLY SLIGHT PAIN AND PROBLEMS.

  Patient problems: Pneumonia; Thrombosis/Thrombus

  MAUDE report 12406666 ↗

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