DJO SURGICAL 402-32-010Recalls & reported problems
Djo, LLC · 32mm FEMORAL HEAD, +10mm · Class 2 · Implant
All models of DJO SURGICAL (42)
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 00888912076555), received between May 10, 2021 and May 10, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Naturally Worn” (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
- Naturally Worn1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2021Naturally Worn
REVISION SURGERY - DUE TO A ZIMMER ACEBABULAR CUP AND LINER IN PATIENT, AN EXACTEEH STEM AND A DJO CHROME 3Z +10.5 FEMORAL HEAD IN PATIENT. THE REASON FOR REVISION WAS ECCENTRIC WEAR OF POLY INSERT. SURGEON REMOVED THE HEAD AND TRIED A CERAMIC DELTA OPTIONS 32MM HEAD WITH +7MM NECK. STEMS TRUNIM WAS VERY WORN AND WOULD NOT GRIP NEW NECK AND HEAD. OLD 32MM +10.5 HEAD WAS RE-IMPLANTED ON F. TRUNIM AND ZIMMER POLY WAS CHANGED.
Patient problems: Failure of Implant
MAUDE report 11796445 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
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- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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