X3 1236-2-864Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540639059), received between May 7, 2019 and May 17, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR REVISION OF THE PATIENT'S RIGHT HIP ON (B)(6) 2022. PATIENT HAD AN INDEX RIGHT THA OUTSIDE OF CORS SCOPE. THE PATIENT WAS REVISED FOR SQUEAKING ON (B)(6) 2022. ONLY THE MDM LINER AND HEAD WERE EXCHANGED. THE PATIENT DEVELOPS PJI REQUIRING A SECOND RIGHT THA REVISION ON (B)(6) 2022. ONLY THE MDM LINER AND HEAD WERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 16944296 ↗
• InjuryFeb 17, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. PRIOR TO REVISION, THE PATIENT PRESENTED TO THE E.R. FOR AN UNSUCCESSFUL CLOSED REDUCTION AND THE DECISION WAS MADE TO REVISE THE HIP. INTRA-OPERATIVELY, THE ADM/ MDM POLY WAS OBSERVED TO BE DISLOCATED FROM THE ADM SHELL, AND DISSOCIATED FROM THE FEMORAL HEAD. AS THE SURGEON WANTED TO GO WITH A SMALLER INSERT/ HEAD OPTION, THE DECISION WAS MADE TO REVISE THE SHELL, HEAD AND LINER.

  Patient problems: Joint Dislocation

  MAUDE report 11340303 ↗
• InjuryJul 7, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE BIOLOX HEAD FROM THE ADM/ MDM POLY INSERT. THE DEVICES WERE REVISED TO A UNIVERSAL BIOLOX HEAD WITH SLEEVE AND A NEW ADM POLY. REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 10238336 ↗
• InjuryMay 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS PER MEDICAL REVIEW, "ON (B)(6) 2016 AN INFECTIOUS DISEASE CONSULT NOTES A RECENT (B)(6) AND CANDIDA ALBICANS PROSTHETIC JOINT INFECTION. THE PATIENT WAS TO CONTINUE WITH A WOUND VAC. ON (B)(6) 2016 THE PATIENT HAD A MEDICAL ADMISSION FOR HEADACHES AND CONFUSION, AND WAS DISCHARGED TO A SKILLED NURSING FACILITY ON (B)(6) 2016 WITH A DIAGNOSIS OF ACUTE KIDNEY PROBLEMS SECONDARY TO VANCOMYCIN NEPHROTOXICITY AND SEPSIS SECONDARY TO RECURRENT INFECTION RIGHT HIP. THE NOTE STATES, "ORTHO DECIDED NO SURGICAL INTERVENTION.""

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8588613 ↗