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X3 1236-2-856Recalls & reported problems

Howmedica Osteonics Corp. · X3 Insert · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540639011), received between Aug 16, 2019 and Aug 16, 2019 — classified as 2 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 16, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information2

Patient problems

  • Pain2
  • Discomfort1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    THIS PATIENT IS A SUBJECT IN (B)(6) STUDY. AT THE SUBJECT'S 6-YEAR FOLLOW-UP THE SUBJECT REPORTED OCCASIONAL, MILD PAIN THAT DOES NOT INTERFERE IN HIS DAILY ACTIVITIES. THE SUBJECT INDICATED HE WAS OVERALL SATISFIED WITH THE RESULTS OF HIS HIP REPLACEMENT.

    Patient problems: Pain

    MAUDE report 8902602 ↗
  • InjuryAug 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    THIS PATIENT IS A SUBJECT IN STRYKER ADM X3 ACETABULAR SYSTEM STUDY. AT THE SUBJECT'S 7-YEAR FOLLOW UP VISIT, HE INDICATED HE HAD PAIN THAT WAS "UNCERTAIN AS TO ORIGIN, IMMEDIATE AREA ON HIP ONLY - SOME DISCOMFORT, NO INTENSE PAIN." SUBJECT REPORTED HE WAS OVERALL SATISFIED WITH THE RESULTS OF HIS HIP REPLACEMENT.

    Patient problems: Discomfort; Pain

    MAUDE report 8902393 ↗

Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices →

Sources and updates

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