X3 1236-2-846Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540665904), received between Mar 21, 2018 and Nov 14, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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

• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT IS A SUBJECT IN STRYKER ADM X3 ACETABULAR SYSTEM STUDY. AT THE SUBJECT'S 6-YEAR FOLLOW UP VISIT, SHE REPORTED SHE HAS PAIN IN HER STUDY HIP AND IS NOT SATISFIED WITH THE RESULTS OF HER HIP REPLACEMENT. SHE INDICATED THIS WAS THE FIRST TIME SINCE HER REPLACEMENT THAT SHE WAS FEELING PAIN. UPDATE: "LEFT" HIP. UPDATE: MED RECORDS, OP REPORTS, PROGRESS NOTES, AND PATH/LAB REPORTS "NOT AVAILABLE AS ENROLLED IN CLINICAL STUDY".

  Patient problems: Pain

  MAUDE report 15789052 ↗
• InjuryJul 20, 2022Unstable; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Unstable; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THE END USER REPORTED AN OFF-LABEL SITUATION THAT NEEDS CLARIFICATION, DETAILS AS FOLLOWS. TOTAL HIP REPLACEMENT INVOLVING THE FOLLOWING ITEMS: 6720-0435 SIZE 4 ACCOLADE II 132 DEG 1, 6570-0-228 DELTA V-40 CERAMIC HEAD 28/+4 1, 542-11-56F TRIDENT PSL WITH PUREFIX HA 1, 626-00-46F MODULAR DUAL MOBILITY INSERT 1, 1236-2-846 RESTORATION ADM X3 INS 28/46 1. POST-OP X-RAY ALSO PROVIDED. THE END USER USED THE ITEM 1236-2-846 RESTORATION ADM X3 28/46 AS THIS IS THE ITEM THAT THEY HAD AVAILABLE DURING THE CASE. AS IT IS WRITTEN ON THE BOX THAT IS SHOULD NOT BE USED ON AN MDM LINER HE IS WORRIED THAT IT WILL FAIL. BUT DURING TRIAL DURING REDUCTION BEFORE CLOSING THERE IS NO ADVERSE EFFECT AND NO DISLOCATION. THE END USER BELIEVED THAT THE ITEM IS THE SAME SIZE AND SHAPE, AND JUST NEEDS A CLARIFICATION IF USING THE ITEM OFF-LABEL WILL CAUSE AN EFFECT IN THE LONGEVITY OF THE IMPLANTS. THE END USER IS ASKING IF THEY NEED TO REPLACE THIS IMPLANTS THAT WE HAVE ON HAND TO AVOID ANY CONFUSION IN THE FUTURE. THE END USER MENTIONED THAT THEY ONLY BOUGHT THEM BASE ON THE SUGGESTIONS. NOW THE SURGEON IS ASKING FOR A LETTER TO CLARIFY THIS ISSUE.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 15064033 ↗
• InjuryApr 23, 2018Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT WRONG ACETABULAR INSERT WAS ALLEGEDLY IMPLANTED WITH AN ADM CUP. ON (B)(6) 2018 UPDATE: ADDITIONAL SURGERY TO CHANGE LINER.

  Patient problems: Injury

  MAUDE report 7450577 ↗
• InjuryMar 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION. REP REPORTED THAT ALL IMPLANTS WERE REMOVED FROM THE PATIENT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7358931 ↗