DJO SURGICAL 497-40-000Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, COCR, 40MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888912024068), received between Apr 12, 2016 and Sep 9, 2026 — classified as 16 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 Problem5
- Device Dislodged or Dislocated5
- Appropriate Device Problem Term/Code Not Available4
- Insufficient Device Problem Information2
Patient problems
- Joint Dislocation3
- No Code Available2
- Pain2
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bone Fracture(s)1
- Failure of Implant1
- Fall1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bone Fracture(s); Fall
MAUDE report 50702449 ↗InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT EXPERIENCED SOME PAIN SURGEON SUSPECTED INFECTION.
Patient problems: Pain
MAUDE report 15210938 ↗InjuryApr 1, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO METALLOSIS AND OSTEOLYSIS. REMOVED AND EXCHANGED OUT THE LINER, HEAD AND SLEEVE.
Patient problems: Metal Related Pathology; Osteolysis
MAUDE report 13979785 ↗InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - HEAD AND SLEEVE REPLACED DUE TO ACUTE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 13231579 ↗InjurySep 3, 2021Appropriate Device Problem Term/Code Not Available
InjuryMar 11, 2021Device Dislodged or Dislocated
SECOND REVISION SURGERY - PATIENT DISLOCATED AND NEEDED REVISION SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11461789 ↗InjuryFeb 18, 2021Insufficient Device Problem Information
REVISION SURGERY - DUE TO HEAD SWAP.
Patient problems: Insufficient Information
MAUDE report 11342723 ↗InjuryJul 16, 2020Appropriate Device Problem Term/Code Not Available
InjurySep 12, 2019Device Dislodged or Dislocated
SECOND REVISION SURGERY - PATIENT RECURRING DISLOCATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9010343 ↗InjuryMay 13, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PAIN. HEMI HIP WAS CONVERTED INTO A TOTAL HIP. THE SURGEON REMOVED THE HEAD AND SLEEVE, THEN ADDED A SHELL, LINER, AND HEAD.
Patient problems: Pain
MAUDE report 8605650 ↗InjuryJan 16, 2019Device Dislodged or Dislocated
InjuryApr 17, 2018Insufficient Device Problem Information
REPORTED INCIDENT - THE PATIENT IS EXPERIENCING METALLOSIS PROBLEMS, LIKELY TO HAVE A REVISION SURGERY.
Patient problems: Toxicity
MAUDE report 7437922 ↗InjuryAug 26, 2016Device Dislodged or Dislocated
REVISION SURGERY - DUE TO CHRONIC DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 5908633 ↗InjuryApr 12, 2016Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT CHRONICALLY DISLOCATING.
Patient problems: No Code Available
MAUDE report 5572535 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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