DJO SURGICAL 495-01-065Recalls & reported problems
Encore Medical, L.P. · EXPRT Revision Hip, Lateral Offset Proximal Body, 65mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 1
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00190446153849), received between Jun 26, 2018 and Sep 15, 2026 — classified as 1 death, 22 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 Problem8
- Appropriate Device Problem Term/Code Not Available7
- Device Dislodged or Dislocated5
- Loose or Intermittent Connection2
- Unstable2
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
- No Apparent Adverse Event1
Patient problems
- Insufficient Information7
- Joint Dislocation6
- Joint Laxity3
- Pain3
- Limb Fracture2
- No Known Impact Or Consequence To Patient2
- Bone Fracture(s)1
- Failure of Implant1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
DeathSep 15, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 10, 2026Unstable
THE PATIENT DISLOCATED. THE PROXIMAL BODY WAS EXCHANGED TO INCREASE LENGTH AND A DUAL MOBILITY INSERT WAS USED.
Patient problems: Joint Dislocation
MAUDE report 24845272 ↗InjuryMar 2, 2026Unstable
InjuryOct 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT REQUIRED REVISION SURGERY TO REMOVE PROXIMAL BODY DUE TO DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 23240798 ↗InjurySep 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT AN ACETABULAR REVISION WAS PERFORMED ON A MEDACTA CUP. SURGEON ELECTED TO REMOVE THE PROXIMAL BODY OF A WELL-FIXED EXPRT HIP FEMORAL STEM TO GAIN ACCESS TO THE CUP. A NEW PROXIMAL BODY AND FEMORAL HEAD WERE IMPLANTED. NO ISSUES WERE REPORTED WITH THE ENOVIS COMPONENTS.
Patient problems: Insufficient Information
MAUDE report 23100887 ↗InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY FOR REASON UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20931992 ↗InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 20023052 ↗InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 11, 2024No Apparent Adverse Event; No Apparent Adverse Event
REVISION SURGERY - DUE TO DR. REVISED PROXIMAL BODY TO A 75 LATERAL & ADDED NEW HEADBALL.
Patient problems: Insufficient Information
MAUDE report 18882639 ↗InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DR. REVISED EXPRT PROXIMAL BODY & CERAMIC HEAD.
Patient problems: Joint Laxity
MAUDE report 17687356 ↗InjuryFeb 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: PATIENT FELL AND BROKE FEMUR.
Patient problems: Bone Fracture(s); Limb Fracture
MAUDE report 16301448 ↗InjuryAug 2, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT HAD A DISLOCATION. THE 65MM PROXIMAL BODY OF THE FEMORAL COMPONENT WAS REVISED TO A 85MM IMPLANT FOR INCREASED STABILITY. THE +4 LINER WAS SWITCH TO A DUAL MOBILITY CONSTRUCT AND THE HEAD LENGTH WAS SWITCHED FROM +4 TO +7.
Patient problems: Insufficient Information
MAUDE report 15153868 ↗InjuryApr 13, 2022Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - THE PATIENT DISLOCATED AFTER A REVISION TOTAL HIP ARTHROPLASTY. WHEN SURGEON EVALUATED THE POSITION OF THE PROXIMAL BODY ON THE EXPRT HIP STEM THE STEM WAS LOOSE AND THE VERSION ON THE BODY WAS INADEQUATE. THE VERSION ON THE PROXIMAL BODY WAS NEUTRAL AT BEST. HE DOES NOT BELIEVE HE IMPLANTED THE DEVICE THIS WAY AND SPECULATES THE MORSE TAPER OF THE PROXIMAL BODY MAY HAVE LOOSENED AND ROTATED.
Patient problems: Joint Dislocation
MAUDE report 14105060 ↗InjuryDec 13, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT BECAME UNSTABLE.
Patient problems: Insufficient Information
MAUDE report 12987126 ↗InjuryOct 12, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS DISLOCATING SO WE SWAP HEAD AND PROXIMAL BODY FOR MORE STABILITY.
Patient problems: Insufficient Information
MAUDE report 12618992 ↗InjuryAug 26, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - SURGEON, THOUGHT THE STEM WAS LOOSE BUT WAS WELL FIXED HE LEFT THE STEM AND REPLACED THE PROXIMAL BODY AND HEAD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10454231 ↗InjuryOct 23, 2019Appropriate Device Problem Term/Code Not Available
InjuryJun 21, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT DISLOCATING. THE SURGEON PUT IN A CONSTRAINED LINER AND CHANGED HEAD AND PROXIMAL BODY.
Patient problems: Joint Dislocation
MAUDE report 8722027 ↗InjuryApr 5, 2019Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8487692 ↗InjuryJul 5, 2018Loose or Intermittent Connection
REVISION SURGERY - DUE TO A LOOSE PROXIMAL BODY BOLT. ALL DJO COMPONENTS CAME OUT AND DIFFERENT VENDOR WAS IMPLANTED.
Patient problems: Failure of Implant; No Code Available
MAUDE report 7663928 ↗InjuryJun 26, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT FALLING AND DISLOCATING.
Patient problems: Joint Dislocation; Pain
MAUDE report 7638683 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, uncemented devices
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- Endo-Model SL Knee Prosthesis System 16-2840/02WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall17 reports
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- Trident 623-10-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented57 reports
- LFIT 6260-9-336Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented56 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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