Biolox® Option 00-8777-028-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024430440), received between Dec 23, 2019 and Sep 29, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.

• InjurySep 29, 2026Device Dislodged or Dislocated

  Patient problems: Joint Contracture; Joint Dislocation; Scar Tissue

  MAUDE report 50933410 ↗
• InjuryJan 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD DISLOCATION, DURING SURGICAL INTERVENTION PATIENT APPEARED TO PRESENT WITH TRUNION WEAR AND PSEUDOTUMOR POSSIBLY FROM METAL ION RELEASE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Joint Dislocation

  MAUDE report 18424470 ↗
• InjuryOct 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT A REVISION SURGERY DUE TO DISLOCATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 12680679 ↗
• InjuryMay 26, 2021Degraded; Material Integrity Problem; Degraded; Material Integrity Problem

  PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT A REVISION SURGERY DUE TO EXCESSIVE SCUFFING PRESENT ON THE DUAL MOBILITY BEARING. THE PATIENT HAD A FALL AND FRACTURED DISTALLY THE STEM. THE FEMORAL FRACTURE IS MARKED AS CONTRIBUTING CONDITION FOR THIS SCUFFING.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 11885405 ↗
• InjuryDec 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THE INVESTIGATION TASKS, IT WAS NOTICED THAT THE DEVICE HERE REPORTED IS ACTUALLY THE DEVICE WHICH WAS IMPLANTED DURING THE REVISION SURGERY ON (B)(6) 2019. IDENTIFICATION OF THE EXPLANTED DEVICES REMAIN UNKNOWN. FURTHERMORE, WARSAW REPORTED AN UNKNOWN HEAD IN THEIR COMPLAINT (B)(4) (MDR REPORT 0001822565-2019-05345). THIS IS WHY THIS COMPLAINT IS GOING TO BE INVALIDATED. PLEASE VOID THIS REPORT FROM YOUR DATABASE.

  Patient problems: No Information

  MAUDE report 9509711 ↗