BIOLOX® Delta Hip System 12-115109Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868248405), received between Mar 4, 2020 and Mar 17, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2022Failure to Osseointegrate; Osseointegration Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Failure to Osseointegrate; Osseointegration Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED, THAT: A PATIENT UNDERWENT LEFT THA ON (B)(6) 2019 BY (B)(6). SUBSEQUENTLY, A REVISION PROCEDURE OF LEFT THA DUE TO ASEPTIC LOOSENING OF THE FEMORAL STEM BY (B)(6) WAS PERFORMED ON (B)(6) 2022. FINDINGS: (B)(6) 2021; OFFICE VISIT. CONTRALATERAL HIP PERFORMED (B)(6) 2021. FOLLOW UP VISIT FOR RIGHT THA WHICH IS DOING WELL; LEFT HIP INCREASING PAIN WITH AMBULATION, NOW USING A CANE. X-RAY: OVERALL WELL ALIGNED, SOME AREAS OF RADIOLUCENCIES WITH SCALLOPING AROUND THE FEMORAL STEM. PLAN FOR LEFT HIP REVISION. ON (B)(6) 2022; REVISION. REVISION DUE TO ASEPTIC LOOSENING; NO INGROWTH OF THE FEMORAL STEM NOTED; SHELL WELL FIXED AND LEFT IN PLACE; ARCOS STEM ATTEMPTED BUT SURGEON NOT SATISFIED WITH THE POSITION, WAGNER USED INSTEAD; HEAD AND STEM REPLACED WITHOUT COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 13800382 ↗
• InjuryMar 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A CLINICAL STUDY REPORTED THE PATIENT RECEIVED A RIGHT HIP ARTHROPLASTY, AND EXPERIENCED A STITCH ABSCESS SHORTLY AFTER THE PROCEDURE. MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Abscess

  MAUDE report 9786020 ↗

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