DJO SURGICAL 495-00-065Recalls & reported problems
Encore Medical, L.P. · EXPRT Revision Hip, Standard Offset Proximal Body, 65mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical hip implant is used in hip replacement surgery. FDA reports mostly describe the joint dislocating or becoming unstable, along with infections, sometimes requiring revision surgery. There are 23 reports, including 21 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
- 23
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00190446153818), received between Dec 28, 2017 and Aug 17, 2026 — classified as 21 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 Dislocated4
- Unstable4
- Loose or Intermittent Connection3
- Appropriate Device Problem Term/Code Not Available1
- Excessive Cooling1
- Inadequacy of Device Shape and/or Size1
- Insufficient Device Problem Information1
Patient problems
- Joint Dislocation7
- Joint Laxity5
- Unspecified Infection5
- Insufficient Information3
- No Known Impact Or Consequence To Patient2
- Failure of Implant1
- Fall1
- Implant Pain1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2026Unstable; Device Dislodged or Dislocated
Revision Surgery - Due to These patient dislocated and was unstable.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 50289079 ↗InjuryApr 6, 2026Device Dislodged or Dislocated
InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 30, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO NEEDED ADDITIONAL VERSION AND LENGTH.
Patient problems: Insufficient Information; Joint Laxity
MAUDE report 19494864 ↗InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DR. REMOVED HEADBALL & 65 BODY & REPLACED WITH NEW HEADBALL & NEW EXPERT BODY.
Patient problems: Insufficient Information
MAUDE report 19397982 ↗InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION AND INFECTION
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 17971377 ↗InjuryMay 16, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY AND DISLOCATION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 16943079 ↗InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT PRESENTED WITH SUBLUXATION. X RAYS SUGGESTED POSSIBLE SUBSIDENCE OF THE IMPLANT.
Patient problems: Joint Dislocation
MAUDE report 15626675 ↗InjuryJun 15, 2022Unstable
InjuryMay 10, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 14346381 ↗InjuryFeb 28, 2022Insufficient Device Problem Information
REVISION SURGERY IMPLANTS FROM A DIFFERENT COMPANY ON ACETABULUM SIDE BECAME LOOSE, HAD TO REMOVE THE PARTS TO REVISE.
Patient problems: Failure of Implant
MAUDE report 13623141 ↗InjuryApr 1, 2021Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated
REVISION SURGERY - PATIENT DISLOCATED. SO SURGEON PUT ON A LONGER PROXIMAL BODY.
Patient problems: Joint Dislocation
MAUDE report 11605198 ↗InjuryDec 30, 2019Excessive Cooling
REVISION SURGERY - THE ORIGINAL SURGERY WAS PERFORMED FOR REVISION OF A HEMI THAT HAD BEEN DISLOCATED A YEAR. THE CONSTRUCT WAS STABLE THROUGH A RANGE OF MOTION. FIVE WEEKS POST OPERATION THE PATIENT DISLOCATED AT WHICH TIME THE 65MM BODY WAS REPLACED WITH A 75MM BODY. THE REASON 46MM FMP WAS INCLUDED IS THAT THERE IS NO CONSTRAINED LINER OPTION AVAILABLE AT THAT SIZE SO A COMPETITIVE CONSTRAINED LINER HAD TO BE CEMENTED IN.
Patient problems: No Code Available
MAUDE report 9530606 ↗MalfunctionOct 17, 2018Loose or Intermittent Connection
REPORTED INCIDENT - EXPRT LOCKING BOLT SHOWN ON 3-MONTH POST OPERATIVE X-RAY AS OUT OF POSITION, INDICATING LOOSENING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7975311 ↗MalfunctionOct 17, 2018Loose or Intermittent Connection; Nonstandard Device; Positioning Problem
REPORTED INCIDENT - EXPRT LOCKING BOLT SHOWN ON ONE-MONTH POST OPERATIVE X-RAY AS OUT OF POSITION, INDICATING LOOSENING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7975253 ↗InjuryApr 27, 2018Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED.
Patient problems: No Information
MAUDE report 7470332 ↗InjuryDec 28, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION. THE SURGEON REMOVED THE PROXIMAL BODY. THE BOLT THAT HELD THE PROXIMAL BODY IN WAS LOOSE. DID NOT REPLACE THE PROXIMAL BODY.
Patient problems: Unspecified Infection
MAUDE report 7152039 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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