DJO SURGICAL 497-28-035Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, COCR 28/-3.5MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical 28mm cobalt-chrome femoral head is used in hip replacement surgery. The 31 reports mostly describe the hip implant coming loose or dislocating after surgery, along with pain, infection, and bone loss around the joint, with 31 injuries and no deaths. Most reports led to revision surgery to remove or replace the parts. 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
- 31
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00888912087278), received between Sep 28, 2015 and Sep 19, 2023 — classified as 31 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 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.
Most reported problems
Device problems
- Device Dislodged or Dislocated14
- Appropriate Device Problem Term/Code Not Available9
- Adverse Event Without Identified Device or Use Problem4
- Insufficient Device Problem Information2
- Device Damaged by Another Device1
- Loose or Intermittent Connection1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Malposition of Device1
Patient problems
- No Code Available10
- Insufficient Information3
- Joint Dislocation3
- No Known Impact Or Consequence To Patient3
- Pain3
- Unspecified Infection3
- Failure of Implant2
- Joint Laxity2
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND FRACTURE.
Patient problems: Implant Pain; Limb Fracture
MAUDE report 17778208 ↗InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 14, 2022Appropriate Device Problem Term/Code Not Available
InjuryMay 12, 2022Output Problem
REVISION SURGERY - PATIENT HAD METAL ON METAL HIP DONE, RESULTING IN OSTEOLYSIS.
Patient problems: Osteolysis
MAUDE report 14375882 ↗InjuryMay 10, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PATIENT STILL DISLOCATING SO SURGEON EXPLANTED EVERYTHING AND DID A FULL REVISION HIP.
Patient problems: Insufficient Information
MAUDE report 14346369 ↗InjuryMar 1, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT DISLOCATED POST OPERATION. SURGEON DECIDED TO DO A HEAD EXCHANGE. SUBSEQUENTLY DECIDED TO CHANGE FROM A BIPOLAR TO UNIPOLAR.
Patient problems: Joint Dislocation
MAUDE report 13635891 ↗InjuryDec 20, 2021Unstable; Device Dislodged or Dislocated
REVISION SURGERY - HEAD CUP AND LINER WERE REMOVED DUE TO INSTABILITY AND DISLOCATION. CUP AND LINER WERE REPLACED WITH A LARGER CUP AND DUAL MOBILITY LINER FROM STRYKER. OUR 28 NEUTRAL HEAD WAS IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 13046949 ↗InjuryNov 29, 2021Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - PATIENT ACETABULAR CUP WAS LOOSE AND MAL-ALIGNED.
Patient problems: Joint Laxity
MAUDE report 12882851 ↗InjuryNov 11, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Insufficient Information
MAUDE report 12798758 ↗InjuryApr 5, 2021Appropriate Device Problem Term/Code Not Available
InjuryFeb 5, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO UNKNOWN REASONS.
Patient problems: Insufficient Information
MAUDE report 11285749 ↗InjuryJun 25, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
THIRD REVISION SURGERY - PATIENT'S HIP DISLOCATED. REMOVED DJO HEAD AND "OTHER" VENDORS CUP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10195559 ↗InjuryApr 14, 2020Device Dislodged or Dislocated
InjuryMar 24, 2020Device Dislodged or Dislocated
InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS COMPLAINING OF HIP PAIN. HEAD WAS REMOVED AND REPLACED.
Patient problems: Pain
MAUDE report 9444553 ↗InjuryNov 21, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS IN DISCOMFORT AND PAIN.
Patient problems: Discomfort; Pain
MAUDE report 9355831 ↗InjuryAug 22, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE INNER HEAD (28MM) HAVING DISASSOCIATED WITH THE OUTER BIPOLAR HEAD (51MM). THE ORIGINAL COMPONENTS WERE REMOVED AND REPLACED WITH THE COMPONENTS ON THIS ORDER. THE ORIGINAL CASE WAS DONE 2 DAYS PRIOR.
Patient problems: No Information
MAUDE report 8923493 ↗InjuryMay 30, 2019Device Damaged by Another Device
REVISION SURGERY - DUE TO THE HEAD HAVING WORN THROUGH THE LINER AND DAMAGED THE CUP. THE HEAD, CUP, AND LINER WERE REPLACED. ANOTHER VENDOR WAS USED TO REPLACE THE CUP AND LINER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8653881 ↗InjuryMay 7, 2019Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT DISLOCATING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8587697 ↗InjuryNov 21, 2018Material Separation
REVISION SURGERY - DUE TO METAL HEAD DISASSOCIATING FROM POLY LINER. LEFT SIDE HIP. THE SURGEON REMOVED THE METAL/METAL LINER AND HEAD.
Patient problems: No Code Available
MAUDE report 8095727 ↗InjuryMay 30, 2018Device Dislodged or Dislocated
InjuryMar 30, 2018Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE NECK DISSOCIATING FROM THE STEM. THE SURGEON CEMENTED THE NECK INTO PLACE AND REPLACED THE HEAD.
Patient problems: No Code Available
MAUDE report 7386465 ↗InjuryFeb 23, 2018Device Dislodged or Dislocated
REVISION SURGERY - DUE TO DISLOCATION. THE SURGEON REVISED BIPOLAR TO ACETABULAR CUP AND LINER.
Patient problems: No Code Available
MAUDE report 7292266 ↗InjuryNov 27, 2017Device Dislodged or Dislocated
SECOND REVISION SURGERY - DUE TO THE PATIENT DISLOCATING THEIR HIP. THE PATIENT PREVIOUSLY HAD A CONSTRAINED LINER. THE SURGEON REPLACED THE CONSTRAINED LINER.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 7060390 ↗
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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