DJO SURGICAL 436-28-007Recalls & reported problems
Encore Medical, L.P. · LINER, ACETABULAR, FMP CONSTRAINED 28XMP7 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888912085700), received between Apr 18, 2018 and Sep 12, 2024 — classified as 8 injuries.
The most frequently reported specific device problem is “Break” (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
- Appropriate Device Problem Term/Code Not Available5
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Defective Component1
- Device Dislodged or Dislocated1
- Improper or Incorrect Procedure or Method1
- Malposition of Device1
- Metal Shedding Debris1
Patient problems
- Failure of Implant2
- Insufficient Information1
- Joint Dislocation1
- No Information1
- Pain1
- Skin Discoloration1
- Unspecified Infection1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO CUP WAS VERTICAL.
Patient problems: Failure of Implant
MAUDE report 16640419 ↗InjuryJun 8, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY DUE TO AN INFECTION. WASHOUT.
Patient problems: Unspecified Infection
MAUDE report 14634444 ↗InjuryJul 22, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT DISLOCATED OUT PREVIOUS IMPLANTED CONSTRAINED LINER.
Patient problems: Insufficient Information
MAUDE report 12213201 ↗InjuryJan 7, 2021Defective Component; Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - THE CONSTRAINED LOCKING RING FAILED. SURGEON CEMENTED IN A STRYKER CONSTRAINED LINER AND CHANGED HEAD TO A 22 MM.
Patient problems: Failure of Implant
MAUDE report 11133588 ↗InjuryAug 30, 2019Improper or Incorrect Procedure or Method; Malposition of Device; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT HAVING PULLED OUT OF THE PREVIOUS CONSTRAINED LINER. THE SURGEON REMOVED THE PREVIOUS COMPONENTS AND REPLACED THEM. HE WILL BE GOING BACK IN, IN THE FUTURE TO REMOVE THE CUP. THE CUP IS IN A VERY VERTICAL POSITION.
Patient problems: No Information
MAUDE report 8951279 ↗InjuryAug 23, 2019Break; Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - PATIENT PRESENTED WITH DISCOLORATION. SHE HAD POSTERIOR IMPINGEMENT FROM THE STEM. THE STEM HAD BROKEN THE LINER. SURGEON CHANGED THE PROXIMAL BODY ON THE STEM (NOT DJO) TO HAVE MORE OFFSET AND MORE HEAD HEIGHT TO RELIEVE IMPINGEMENT. LINER WAS REPLACED.
Patient problems: Skin Discoloration
MAUDE report 8925929 ↗InjuryApr 18, 2018Metal Shedding Debris
SECOND REVISION SURGERY - DUE TO THE PATIENT COMPLAINING OF PAIN DUE TO METALLOSIS.
Patient problems: Pain
MAUDE report 7441248 ↗
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.
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