DJO SURGICAL 497-28-000Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL , COCR 28MM NEUTRAL · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Encore Medical hip implant is a porous, cementless femoral head used in hip replacement. Most of the 48 reports describe the hip coming out of place or feeling unstable, along with pain, falls, and looseness of the joint, with several leading to revision surgery. No deaths were reported, but 48 injuries were. There are no recalls naming 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
- 48
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00888912087254), received between Mar 2, 2016 and Mar 2, 2026 — classified as 48 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (17 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 Problem20
- Device Dislodged or Dislocated17
- Appropriate Device Problem Term/Code Not Available12
- Unstable5
- Detachment Of Device Component1
- Inadequacy of Device Shape and/or Size1
- Patient-Device Incompatibility1
Patient problems
- Joint Dislocation13
- No Code Available9
- Pain6
- Fall5
- Insufficient Information4
- Failure of Implant2
- Joint Laxity2
- No Information2
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - CONVERTED A HEMI TO A TOTAL HIP FEMALE, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24477767 ↗InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND DISLOCATION.
Patient problems: Implant Pain; Joint Dislocation
MAUDE report 22800996 ↗InjurySep 24, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FALL, LOWER BODY/DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 16414696 ↗InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HIP DISLOCATED. WHEN THE EMERGENCY DEPARTMENT TRIED TO REDUCE IT THE HEAD REMAINED ON TRUNNION BUT OTHER COMPONENT ON THE BIPOLAR HEAD WAS DETACHED. REVISION OF HEAD ONLY.
Patient problems: Joint Dislocation
MAUDE report 15888353 ↗InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT HAD AN ENCORE METAL ON METAL TOTAL HIP REPLACEMENT PERFORMED BY SURGEON. PATIENT STARTED EXPERIENCING SOME GENERAL HIP PAIN. AFTER CONSULTING WITH SURGEON, THEY OPTED TO REVISE THE IMPLANTS. DURING SURGERY, THE LINER AND COCR FEMORAL HEAD WERE REMOVED. A POLYETHYLENE LINER WAS IMPLANTED FOR THE 54MM CUP WITH AN ID OF 36MM. A 36MM BIOLOX DELTA OPTION CERAMIC HEAD WITH TI SLEEVE (NEUTRAL) WERE IMPLANTED.
Patient problems: Pain
MAUDE report 14888574 ↗InjuryDec 28, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE HEAD DISLOCATED FROM THE BIPOLAR CUP.
Patient problems: Insufficient Information
MAUDE report 13095911 ↗InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT FELL AFTER HAVING A HEMI-ARTHROPLASTY. THE HIP WAS REVISED WITH A LONGER HEAD AND A GREATER TROCHANTER PLATE TO STABILIZE THE FRACTURE.
Patient problems: Fall
MAUDE report 12798586 ↗InjuryAug 6, 2021Unstable; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISLOCATION/INSTABILITY. SURGEON REMOVED THE METAL/METAL LINER AND HEAD AND REPLACED WITH A NEW POLY AND HEAD. EVERYTHING WENT AS PLANNED.
Patient problems: Joint Dislocation
MAUDE report 12287745 ↗InjuryAug 5, 2021Unstable; Device Dislodged or Dislocated
REVISION SURGERY - INSTABILITY AND DISLOCATION. WE REMOVED THE METAL/METAL LINER AND HEAD.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12281667 ↗InjuryApr 21, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISLOCATION. DID A HEAD AND POLY EXCHANGE.
Patient problems: Insufficient Information
MAUDE report 11704417 ↗InjuryMar 26, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT PRESENTED AT THE HOSPITAL WITH A DISLOCATED HIP. UNFORTUNATELY WE DO NOT HAVE ANY PATIENT RECORDS FOR THE PATIENT AS THEIR HIP WAS DONE OVER 20 YEARS AGO. PATIENT ONLY KNEW THAT SURGEON HAD DONE HIS HIP REPLACEMENT SURGERY. THEY DIDN'T KNOW WHEN IT WAS DONE SO TRACKING IMPLANTS WAS IMPOSSIBLE SURGEON ELECTED TO REMOVE THE DJO CUP AND LINER AND REPLACE WITH ANOTHER COMPANY PRODUCT. WE REPLACED THE 28MM HEAD WITH A NEW DJO 28MM HEAD.
Patient problems: Insufficient Information
MAUDE report 11575346 ↗InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem
InjuryDec 1, 2020Unstable; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - REVISION/ CONVERSION OF A BIPOLAR HIP TO A TOTAL DUE TO INSTABILITY.
Patient problems: Failure of Implant
MAUDE report 10928550 ↗InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT COMPLAIN OF HIP PAIN CHANGE FROM BIPOLAR TO TOTAL.
Patient problems: Pain
MAUDE report 10511236 ↗InjuryJul 22, 2020Appropriate Device Problem Term/Code Not Available
InjuryApr 3, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
InjuryDec 5, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: PATIENT HAD A BIPOLAR HIP THAT WAS REVISED TO A TOTAL HIP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9416561 ↗
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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