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
- BIOSTOP 5463-12-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall6 reports
- BIOSTOP 5463-08-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall1 report
- BIOSTOP 5463-18-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall1 report
- BIOSTOP 5463-16-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall1 report
- BIOSTOP 5463-20-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall0 reports
- NA 0306703000Stryker Corporation · CEMENT OBTURATOR1 recall0 reports
- ACM BioPrep 0306705000Stryker Corporation · CEMENT OBTURATOR1 recall0 reports
- PREP-IM 121010Smith & Nephew, Inc. · CEMENT OBTURATOR10 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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