DJO SURGICAL 436-28-000Recalls & reported problems
Encore Medical, L.P. · LINER, LOCKING RING, CONSTRAINED · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888912085663), received between Mar 22, 2016 and Jan 26, 2026 — classified as 17 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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
- Device Dislodged or Dislocated8
- Appropriate Device Problem Term/Code Not Available6
- Break6
- Adverse Event Without Identified Device or Use Problem2
- Loose or Intermittent Connection1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Code Available5
- Joint Dislocation4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Fall2
- No Known Impact Or Consequence To Patient2
- Unspecified Infection2
- Insufficient Information1
- Joint Laxity1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryJan 26, 2026Device Dislodged or Dislocated
REVISION SURGERY - DUE TO INFECTION AND DISLOCATION
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 24185485 ↗InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT FELL AND LOCKING RING CAME LOOSE. DISLOCATED.
Patient problems: Fall; Joint Dislocation; Joint Laxity
MAUDE report 15596922 ↗InjuryDec 22, 2021Device Dislodged or Dislocated
REVISION SURGERY - DUE TO DISLOCATION OF FEMORAL HEAD.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13060321 ↗InjuryJun 29, 2021Break; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FELL AND CONSTRAINED LINER WAS DAMAGED REPLACED LOCKING RING.
Patient problems: Fall
MAUDE report 12088861 ↗InjuryMay 20, 2021Device Dislodged or Dislocated; Therapeutic or Diagnostic Output Failure
REVISION SURGERY - LOCKING RING FAILURE, IMPLANT DISLOCATED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11858462 ↗InjuryApr 9, 2021Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - REVISED AN ONKOS PROXIMAL FEMUR. THE LOCKING RING WAS LOCKED, BUT THERE WAS A DISLOCATION, A NEW PRODUCT STYLED PROXIMAL BODY WAS INSTALLED. SURGEON FELT THE NEWER BODY WOULD SOLVE THE ISSUE.
Patient problems: Joint Dislocation
MAUDE report 11645541 ↗InjuryFeb 16, 2021Device Dislodged or Dislocated
THIRD REVISION SURGERY - DUE TO INFECTION AND DISLOCATION.
Patient problems: Unspecified Infection
MAUDE report 11332473 ↗InjuryNov 22, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT BROKE PREVIOUS CONSTRUCT LINER SO DR. (B)(6) REPLACED THE COMPONENTS.
Patient problems: Insufficient Information
MAUDE report 10881691 ↗InjuryOct 3, 2019Break; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - LOCKING RING BROKE. PATIENT HAD TO HAVE A REVISION. THE SURGEON CALLED BIOMET FOR THE REVISION SO WE WERE NOT NOTIFIED ABOUT THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9150839 ↗InjurySep 12, 2019Break; Loose or Intermittent Connection; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - THE RING OR ACETABULAR LINER DISLODGED AND BROKE. EITHER RING MIGHT HAVE BECAME LOOSE CAUSING THE PLASTIC TO BREAK OR THE PLASTIC MIGHT HAVE BROKEN CAUSING THE RING TO LOOSE.
Patient problems: No Information
MAUDE report 9013751 ↗InjuryMar 29, 2019Appropriate Device Problem Term/Code Not Available
THIRD REVISION SURGERY - DUE TO AN UNKNOWN REASON.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8465642 ↗InjuryDec 10, 2018Adverse Event Without Identified Device or Use Problem
InjuryOct 9, 2018Break
THIRD REVISION SURGERY - DUE TO THE LOCKING RING BREAKING ON THE CONSTRAINED LINER. THE SURGEON REPLACED THE LINER, RING, AND HEAD.
Patient problems: No Code Available
MAUDE report 7948875 ↗InjuryJun 26, 2018Break
REVISION SURGERY - DUE TO A BROKEN CONSTRAINED LINER. THE SURGEON REVISED TO A +5 LINER.
Patient problems: No Code Available
MAUDE report 7639037 ↗InjuryJun 22, 2018Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED.
Patient problems: No Code Available
MAUDE report 7630662 ↗InjuryJun 21, 2018Device Dislodged or Dislocated
SECOND REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED FROM HER CONSTRAINED LINER.
Patient problems: No Code Available
MAUDE report 7626224 ↗InjuryMar 22, 2016Break; Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT DISLOCATING HER HIP AND BREAKING THE CONSTRAIN LINER LOCKING RING.
Patient problems: Joint Dislocation
MAUDE report 5517490 ↗
Other Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer devices
- Novation 134-36-45Exactech, Inc. · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2 recalls0 reports
- PINNACLE 1218-28-650Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer89 reports
- Trident 690-00-28FHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall37 reports
- Trident 690-00-22EHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall36 reports
- PINNACLE 1218-32-652Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer75 reports
- Trident 690-00-22DHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall22 reports
- PINNACLE 1218-32-654Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer70 reports
- Trident 69-2850Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 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