DJO SURGICAL 400-01-221Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL COCR 22MM NEUTRAL · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical femoral head is a component used in cemented hip replacement. Reports mostly describe hip dislocation or instability leading to revision surgery, with a few mentioning infection. There are 23 adverse event reports that name its identifier, with no deaths and 23 injuries. 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
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00888912075626), received between Jan 3, 2018 and Jun 18, 2026 — classified as 23 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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
- Adverse Event Without Identified Device or Use Problem12
- Device Dislodged or Dislocated10
- Appropriate Device Problem Term/Code Not Available3
- Unstable1
Patient problems
- Joint Dislocation8
- Joint Laxity3
- No Known Impact Or Consequence To Patient3
- Failure of Implant2
- No Code Available2
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fall1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2026Device Dislodged or Dislocated
InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 3, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY AND INFECTION.
Patient problems: Joint Laxity
MAUDE report 19244312 ↗InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FEMORAL HEAD POSITION MOVED.
Patient problems: Joint Laxity
MAUDE report 17283454 ↗InjuryJun 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT WAS EXPERIENCING DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 16153495 ↗InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS EXPERIENCING PAIN AND SURGEON SUSPECT INFECTION.
Patient problems: Medical device site infection; Pain
MAUDE report 15523517 ↗InjuryApr 28, 2021Device Dislodged or Dislocated
THIRD REVISION SURGERY - PATIENT WAS DISLOCATING SO THE SURGEON TOOK THE CUP OUT AND REPLACED WITH STRYKER MDM, AND SWAPPED OUR HEAD.
Patient problems: Failure of Implant
MAUDE report 11738508 ↗InjuryFeb 10, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT DISLOCATED. SURGEON REMOVED THE BIPOLAR AND WENT TO A LONGER LENGTH.
Patient problems: Failure of Implant
MAUDE report 11307542 ↗InjuryNov 4, 2020Device Dislodged or Dislocated
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10784504 ↗InjuryJul 2, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT'S BIPOLAR HEMI ARTHROPLASTY KEPT DISLOCATING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10224690 ↗InjuryJun 3, 2020Device Dislodged or Dislocated
REVISION SURGERY - PATIENT FELL AND DISLOCATED INNER DIAMETER 22. HEAD DISASSOCIATED FROM 42 OUTER DIAMETER HEAD.
Patient problems: Fall
MAUDE report 10114739 ↗InjuryMar 20, 2020Device Dislodged or Dislocated
REVISION SURGERY - DISLOCATED, UNKNOWN IF THE PATIENT HAD ANY TRAUMA.
Patient problems: No Code Available
MAUDE report 9860735 ↗InjuryJan 24, 2020Device Dislodged or Dislocated
REVISION SURGERY - PATIENT ENDED UP DISLOCATING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9628037 ↗InjurySep 18, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HIP DISLOCATED. REMOVED AND REPLACED ALL ORIGINAL IMPLANTS EXCEPT THE STEM.
Patient problems: Joint Dislocation
MAUDE report 9085022 ↗InjuryMar 29, 2019Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT'S HIP HAVING DISLOCATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8464803 ↗InjuryJan 3, 2018Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED. THE SURGEON "SWITCHED" FROM BIPOLAR TO TOTAL HIP. HE USED AN ORTHORITY LINER.
Patient problems: No Code Available
MAUDE report 7161639 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page