DJO SURGICAL 436-28-009Recalls & reported problems
Encore Medical, L.P. · LINER, ACETABULAR, FMP CONSTRAINED 28XMP9 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912085731), received between Sep 29, 2017 and Sep 19, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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 Problem1
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Loose or Intermittent Connection1
- Naturally Worn1
- Unstable1
Patient problems
- Failure of Implant2
- Fall1
- Medical device site infection1
- No Code Available1
- No Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO POLY WEAR.
Patient problems: Failure of Implant
MAUDE report 23100889 ↗InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - INFECTION WASHOUT, HEAD AND LINER EXCHANGE.
Patient problems: Medical device site infection
MAUDE report 15790815 ↗InjuryOct 24, 2018Device Dislodged or Dislocated
SECOND REVISION SURGERY - DUE TO THE PATIENT DISLOCATING.
Patient problems: No Information
MAUDE report 8000274 ↗InjuryJan 10, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT FALLING AND BREAKING STEM (NOT DJO). THE SURGEON REPLACED THE LINER SINCE IT WAS DISTURBED DURING SURGERY.
Patient problems: Fall
MAUDE report 7180020 ↗InjuryDec 7, 2017Loose or Intermittent Connection
SECOND REVISION SURGERY - THE SURGEON PERFORMED A POLY EXCHANGE DUE TO THE PATIENT HAVING SOFT TISSUE LOOSENING.
Patient problems: No Code Available
MAUDE report 7096685 ↗InjurySep 29, 2017Unstable
REVISION SURGERY - DUE TO HIP BECOMING UNSTABLE OVER TIME.
Patient problems: Failure of Implant
MAUDE report 6904936 ↗
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