BIOLOX® Delta Hip System 12-115116Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868248450), received between Aug 2, 2022 and Aug 2, 2022 — 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.

• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 8 MONTHS INITIAL RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT DEVELOPED IT BAND SYNDROME AND REQUIRED PHYSICAL THERAPY. SYMPTOMS RESOLVED APPROXIMATELY 5 MONTHS LATER. ALL COMPONENT REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 15151742 ↗

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-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
• 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