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DJO SURGICAL 415-00-140Recalls & reported problems

Encore Medical, L.P. · PLUG, CEMENT SZ. 14.0 · Class 2

Data updated Oct 18, 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 00888912023474), received between Sep 16, 2022 and Sep 16, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device Handling Problem” (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

Device problems

  • Device Handling Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjurySep 16, 2022Device Handling Problem; Device Handling Problem

    INSTRUMENT FAILURE - PHYSICIAN WAS DOING A HEMI HIP ARTHROPLASTY FOR A HIP FRACTURE. CEMENT RESTRICTORS, PREP, AND INSERTION TOOLS WERE ON BACK ORDER AT THE HOSPITAL. WE PROVIDED PHYSICIAN WITH TEKNIMED CEMENT INSTRUMENTATION. THE DISTAL METAL OLIVE GOT STUCK IN THE PATIENTS FEMUR WHEN PLACING THE CLEARCUT CEMENT RESTRICTOR. THE PHYSICIAN COULD NOT REMOVE THE METAL OLIVE. THE TREADS CONNECTING THE T-HANDLE INSERTION TOOL TO THE METAL OLIVE BROKE. PHYSICIAN HAD TO LEAVE THE CEMENT RESTRICTOR AND METAL OLIVE IMPLANTED INSIDE THE PATIENT. DJO'S SMALLEST CEMENTED SYSTEM SAT PROUD BECAUSE THE DISTAL STEM WAS TOUCHING THE METAL OLIVE. PHYSICIAN HAD TO USE A COMPETITIVE SYSTEM BECAUSE OUR CEMENTED STEMS WERE TOO LONG.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15439588 ↗

Other CEMENT OBTURATOR devices

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Sources and updates

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