BIOLOX® Delta Hip System 12-115111Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868248429), received between Apr 1, 2025 and Apr 1, 2025 — 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.

• InjuryApr 1, 2025Device 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 APPROXIMATELY 5 YEARS AND 6 MONTHS POST-IMPLANTATION, THE PATIENT INDICATED THAT THEY WILL BE UNDERGOING A PLANNED HIP REVISION SURGERY. REASON FOR THE REVISION IS CURRENTLY UNKNOWN. IT IS ALSO UNKNOWN IF THE REVISION HAS TAKEN PLACE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Insufficient Information; Joint Dislocation

  MAUDE report 21737383 ↗

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