DJO SURGICAL 497-28-350Recalls & reported problems
Encore Medical, L.P. · FEMORAL HEAD COMPONENTS CoCr Head +3.5 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a metal-on-polymer hip implant femoral head component used in partial hip replacement. The reports mostly describe the hip becoming dislocated or the implant loosening, often after a fall, and needing revision surgery; some mention infection. There are 30 reports, all involving injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00888912024044), received between Sep 28, 2016 and Sep 15, 2026 — classified as 31 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated13
- Adverse Event Without Identified Device or Use Problem10
- Appropriate Device Problem Term/Code Not Available4
- Insufficient Device Problem Information3
- Failure to Align1
- Fracture1
- Inadequacy of Device Shape and/or Size1
- Unstable1
Patient problems
- No Code Available9
- Joint Dislocation8
- No Known Impact Or Consequence To Patient4
- Fall3
- Failure of Implant2
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Arthritis1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Fracture; Device Dislodged or Dislocated
Revision surgery due to dislocation / fracture.
Patient problems: Bone Fracture(s); Joint Dislocation
MAUDE report 50766724 ↗InjuryMar 21, 2026Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT FELL.
Patient problems: Fall; Joint Dislocation
MAUDE report 24657089 ↗InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DR. DID A HEMI HIP ON. THIS PATIENT FELL ON AND DISLOCATED THE HIP AND THE BIPOLAR SHELL AND 28MM HEAD DISASSOCIATED. DR. REVISED THE HIP WITH A LONGER NECK WHICH STABILIZED THE HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 21440150 ↗InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO HEMI CONVERSION TO DUAL MOBILITY.
Patient problems: Implant Pain; Insufficient Information
MAUDE report 20626979 ↗InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 22, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: PATIENT DISLOCATED. SURGEON REPLACED HEAD & SHELL DURING AN OPEN REDUCTION.
Patient problems: Joint Dislocation
MAUDE report 12514938 ↗InjuryJul 19, 2021Device Dislodged or Dislocated
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12189321 ↗InjuryJun 26, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT SUFFERED DISLOCATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10200846 ↗InjuryMar 20, 2020Device Dislodged or Dislocated
InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem
InjuryJul 11, 2019Device Dislodged or Dislocated
REVISION SURGERY - DISLOCATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8783109 ↗InjuryJun 14, 2019Device Dislodged or Dislocated
REVISION SURGERY - DUE TO IMPLANT DISLOCATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8701151 ↗InjuryApr 30, 2019Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT REQUIRING A WASHOUT.
Patient problems: No Code Available
MAUDE report 8566865 ↗InjuryApr 16, 2019Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED.
Patient problems: No Code Available
MAUDE report 8518592 ↗InjuryDec 19, 2018Device Dislodged or Dislocated
THIRD REVISION SURGERY - DUE TO CHRONIC DISLOCATION.
Patient problems: No Code Available
MAUDE report 8181119 ↗InjuryDec 5, 2018Device Dislodged or Dislocated
SECOND REVISION SURGERY - DUE TO A DISLOCATION.
Patient problems: No Code Available
MAUDE report 8133835 ↗InjurySep 26, 2018Adverse Event Without Identified Device or Use Problem
SECOND REVISION SURGERY - DUE TO THE PATIENT HAVING A DISLOCATION WITH DISCOMFORT, NO INFECTION.
Patient problems: Discomfort
MAUDE report 7910957 ↗InjuryOct 23, 2017Device Dislodged or Dislocated
REVISION SURGERY - DUE TO PATIENT DISLOCATION.
Patient problems: No Code Available
MAUDE report 6970244 ↗InjuryAug 1, 2017Appropriate Device Problem Term/Code Not Available
InjuryJul 26, 2017Unstable
REVISION SURGERY - DUE TO THE PATIENT HAVING INSTABILITY IN HIP. THE SURGEON REMOVED AND REPLACED HEAD AND LINER; A SLEEVE WAS ADDED.
Patient problems: Failure of Implant
MAUDE report 6744208 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- 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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