X3 1236-2-850Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540638984), received between May 21, 2018 and Nov 18, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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.

• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: SUBJECT 70-02-004R COMPLETED THE 8-YEAR VISIT BY MAIL FOR THE 70-RESTORATION ADM X3 STUDY. THE SUBJECT COMPLETED THE FOLLOW-UP QUESTIONNAIRE. THE SUBJECT ANSWERED "YES" FOR HIP PAIN WITH THE COMMENT "DULL ACHE MUCH OF THE TIME". THE SUBJECT ANSWERED "NO" FOR SATISFACTION FOR STUDY HIP REPLACEMENT WITH THE COMMENT "I WISH IT DIDN'T ACHE". THE SUBJECT ANSWERED "NO" WITH NO ADDITIONAL COMMENT FOR THE HAVE YOU HAD SURGERY ON YOUR STUDY HIP AND HAS YOUR HIP DISLOCATED SINCE YOUR LAST STUDY VISIT. X-RAYS WERE NOT COMPLETED AS THIS WAS A REMOTE VISIT. THE LAST X-RAYS COLLECTED WERE FROM THE 7-YEAR VISIT.

  Patient problems: Pain

  MAUDE report 15822435 ↗
• InjuryJul 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "LEFT THA REVISION DUE TO DISLOCATION. PATIENT EXPERIENCED DISLOCATION. DURING THE ATTEMPT TO REDUCE HER HIP, THE FORCE BEING APPLIED PRIED THE ADM INSERT OFF OF THE 28MM HEAD". SPOKE TO REP. THE RESTORATION ADM INSERT DISASSOCIATED OUT OF THE RESTORATION ADM SHELL. PATIENT WENT TO ER WHERE A CLOSED REDUCTION WAS ATTEMPTED. DURING THE REDUCTION THE HEAD DISLOCATED OUT OF THE LINER AND THE PATIENT WAS REVISED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8750568 ↗
• InjuryAug 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "RIGHT HIP REVISION DUE TO INTRAPROSTHETIC DISLOCATION¿EXPLANTED A 50/28 ADM X3 POLY". UPDATE 19-JUL-2018: AS REPORTED BY REP: "HEAD WAS DISLOCATED FROM POLY AND ALSO POLY WAS DISLOCATED FROM CUP".

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7784913 ↗
• InjuryMay 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS GETTING AND FELT PAIN IN THEIR HIP. PATIENT WENT TO THE ER AND IT WAS DETERMINED THAT THE PATIENT DISLOCATED HER HIP IMPLANT. THE ER TRIED TO RESET THE HIP AND IN THE PROCESS POPPED OUT THE LINER FROM THE SHELL. THE DOCTOR REPLACED THE LINER AND HEAD.

  Patient problems: Injury; Joint Dislocation; Pain

  MAUDE report 7531222 ↗