DJO SURGICAL 436-28-006Recalls & reported problems
Encore Medical, L.P. · LINER, ACETABULAR, FMP CONSTRAINED 28XMP6 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912085694), received between Jun 13, 2017 and Aug 23, 2022 — classified as 5 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated2
- Break1
- Detachment Of Device Component1
Patient problems
- Failure of Implant1
- Joint Dislocation1
- No Known Impact Or Consequence To Patient1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2022Device Dislodged or Dislocated
REVISION SURGERY - PATIENT HAD RECEIVED A CONSTRAINED LINER FROM A PREVIOUS REVISION SURGERY ON HER LEFT HIP. THE CONSTRAINED LINER FAILED AND THE LEFT HIP DISLOCATED. CUP, LINER, SCREWS AND HEAD WERE REMOVED. A NEW HEAD WITH SLEEVE WAS IMPLANTED, ALONG WITH SMITH & NEPHEW DUAL MOBILITY CUP AND LINER.
Patient problems: Failure of Implant
MAUDE report 15276855 ↗InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT PRESENTED WITH A DISLOCATED HIP. SURGEON REMOVED THE CONSTRAINED LINER AND METAL RING. REPLACED CONSTRAINED LINER AND METAL RING WITH SAME SIZE.
Patient problems: Joint Dislocation
MAUDE report 10975633 ↗InjurySep 14, 2019Break; Device Dislodged or Dislocated
SECOND REVISION SURGERY - THE RING OR THE ACETABULAR LINER DISLODGED AND BROKE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9056632 ↗InjuryApr 23, 2018Detachment Of Device Component
REVISION SURGERY - DUE TO THE PATIENT PRESENTING AT SURGEON'S OFFICE WITH PAIN IN HIP. UPON INSPECTION OF X-RAYS IT WAS DETERMINED THAT THE LOCKING RING AROUND THE CONSTRAINED LINER HAD BECOME DISENGAGED.
Patient problems: Pain
MAUDE report 7451586 ↗InjuryJun 13, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 6638591 ↗
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