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Encompass Hip Stem 114-2010Recalls & reported problems

Ortho Development Corporation · 10mm Cement Restrictor · Class 2 · Implant

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822409012954), received between Dec 7, 2020 and Dec 7, 2020 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K962448); they may or may not involve this specific model.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    POST OPERATIVE IMAGES REVEALED A BONE CRACK THAT IS BELIEVED TO HAVE OCCURRED ON (B)(6)2019 DURING CEMENTLESS BIPOLAR HEMIARTHROPLASTY POSSIBLY WHEN THE STEM WAS INSERTED. A SUBSEQUENT SURGERY WAS PERFORMED AND THE SURGEON APPLIED CABLE TO THE FRACTURE AS WELL AS BONE CEMENT IN CONJUNCTION WITH A 10MM CEMENT RESTRICTOR. POST OPERATIVE IMAGES SHOWED ANTERIOR TWIST SO ANOTHER SURGERY WAS PERFORMED AND THE STEM WAS REMOVED AND REPLACED WITH A STEM MADE BY ANOTHER COMPANY. THE CEMENT RESTRICTOR WAS LEFT IN THE PATIENT. THE ORIGINAL FEMORAL STEM AND THE 10MM BONE RESTRICTOR WERE MANUFACTURED BY THIS COMPANY. THE CABLE, CEMENT, AND SECOND STEM WERE MANUFACTURED BY ANOTHER COMPANY. THIS MDR REPORT IS THE SECOND OF TWO BEING SUBMITTED FOR THIS INCIDENT AND ADDRESSES THE 10MM CEMENT RESTRICTOR.

    Patient problems: Foreign Body In Patient

    MAUDE report 10963289 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962448. One submission often covers many models, so check the product and lot details in each record.

  • Z-0315-2011 · Jul 28, 2010 · Terminated
    Distal Centralizer 10 mm
  • Z-0568-03 · Dec 26, 2002 · Terminated
    Hip Prosthesis as a component of Primaloc Cemented Hip System.

Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices

All Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page