DJO SURGICAL 497-34-000Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, COCR 34MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888912087308), received between Feb 10, 2017 and Apr 11, 2024 — classified as 15 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
- Appropriate Device Problem Term/Code Not Available6
- Device Dislodged or Dislocated5
- Adverse Event Without Identified Device or Use Problem3
- Fracture1
- Insufficient Device Problem Information1
- Patient-Device Incompatibility1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Joint Dislocation3
- No Known Impact Or Consequence To Patient3
- Pain3
- Insufficient Information2
- No Code Available2
- Toxicity2
- Failure of Implant1
- Joint Laxity1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION & INSTABILITY.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 19093726 ↗InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 11, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO IMPLANT UNSTABLE IN PATIENT.
Patient problems: Insufficient Information
MAUDE report 12308014 ↗InjuryJan 25, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - PATIENT HAD DISLOCATION.
Patient problems: Insufficient Information
MAUDE report 11225170 ↗InjuryJun 23, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - PATIENT DISLOCATED HER HIP AGAIN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10185053 ↗InjuryMar 9, 2020Therapeutic or Diagnostic Output Failure
REVISION SURGERY - LEGAL FAILURE OF A METAL/METAL HIP.
Patient problems: No Code Available
MAUDE report 9806087 ↗InjurySep 12, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
InjuryApr 25, 2019Device Dislodged or Dislocated
SECOND REVISION SURGERY - DUE TO A DISLOCATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8551435 ↗InjuryOct 9, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO A METAL ON METAL ISSUE.
Patient problems: No Information
MAUDE report 7949165 ↗InjurySep 14, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO METALLOSIS. THE SURGEON REMOVED THE METAL ON METAL LINER, METAL HEAD.
Patient problems: Toxicity
MAUDE report 7877594 ↗InjuryApr 17, 2018Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING SEVERE LEFT HIP AND GROIN PAIN AND ELEVATED METAL ION LEVELS.
Patient problems: No Code Available; Pain
MAUDE report 7437422 ↗InjuryApr 17, 2018Insufficient Device Problem Information
REVISION SURGERY - DUE TO LEFT GROIN PAIN AND ELEVATED METAL LEVELS.
Patient problems: Pain; Toxicity
MAUDE report 7437126 ↗InjuryApr 13, 2018Patient-Device Incompatibility
REVISION SURGERY - DUE TO A FAILURE, METALLOSIS, PSEUDOTUMOR AND OSTEOLYSIS OF THE ACETABULUM.
Patient problems: Failure of Implant; Osteolysis; Rash; Swelling
MAUDE report 7429764 ↗InjuryJul 21, 2017Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT EXPERIENCING PAIN AND INSTABILITY. THE METAL DISASSOCIATED FROM THE POLY ON THE METAL ON METAL POLY LINER.
Patient problems: Pain
MAUDE report 6734301 ↗InjuryFeb 10, 2017Fracture
REVISION SURGERY: DUE TO THE PATIENT HAVING A PERI-PROSTHETIC FRACTURE; THE SURGEON REMOVED THE STEM AND SLEEVE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6322282 ↗
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.
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