BIOLOX® Delta Hip System 12-115120Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887868248474), received between Aug 27, 2019 and Nov 15, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN. PATIENT UNDERWENT A REPLACEMENT OF THE HEAD COMPONENT THE SAME DAY AS THE INITIAL TOTAL HIP ARTHROPLASTY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Pain

  MAUDE report 15795596 ↗
• InjuryOct 12, 2021Mechanical Problem; Noise, Audible; Mechanical Problem; Noise, Audible

  IT WAS REPORT THAT: THE PATIENT WAS EXPERIENCING IMPINGEMENT AND OR A CLICKING IN HIS HIP. PATIENT CLAIMED THAT HIS HIP WAS DISLOCATING IN MID FLEXION WITH LEG EXTENDED. THE PATIENT HAD SEVERAL X-RAYS, ULTRA SOUND VISITS AND NOTHING SHOWED TO BE DISLOCATED. IMPLANTS WERE IN GOOD POSITIONS AN ACCEPTABLE VERSION WAS USED. DURING PRE OP THE SURGEON WENT THROUGH SEVERAL RANGE OF MOTION TESTS AND THE HIP DID NOT DISLOCATE, BUT THERE WAS A SMALL CLICK WHICH THE SURGEON DETERMINED WAS TIGHTNESS IN THE IT BAND. PATIENT WAS REVISED ON (B)(6) 2021. PATIENT INVOLVEMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Local Reaction

  MAUDE report 12613154 ↗
• InjuryJun 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS STATED THAT THE HIP HAS DISLOCATED AND SUFFERS FROM PAIN.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 10127380 ↗
• InjuryMay 26, 2020No Device Output; Insufficient Device Problem Information; No Device Output; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STUDY PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2020. SUBSEQUENTLY, SHE COMPLAINED OF SEVERE PAIN WITH ACTIVITY AND WAS DIAGNOSED WITH LEFT HIP ILIOPSOAS / FLEXOR TENDONITIS, TROCHANTERIC BURSITIS, AND ABDUCTOR TENDONITIS. NO REVISION HAS BEEN SCHEDULED.

  Patient problems: Inflammation; Pain

  MAUDE report 10086453 ↗
• InjuryAug 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATEINT UNDERWENT PRIMARY RIGHT THA PERFORMED. SUBSEQUENTLY PATIENT EXPERIENCED A HEMATOMA TO RIGHT HIP. NO MEDICAL INTERVENTION WAS REPORTED AND IT WAS NOTED TO HAVE RESOLVED.

  Patient problems: Hematoma

  MAUDE report 8934241 ↗