DJO SURGICAL 436-28-005Recalls & reported problems
Encore Medical, L.P. · LINER, ACETABULAR, FMP CONSTRAINED 28XMP5 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912085687), received between Jul 27, 2021 and Apr 14, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (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
- Appropriate Device Problem Term/Code Not Available2
- Break2
- Adverse Event Without Identified Device or Use Problem1
- Naturally Worn1
Patient problems
- Joint Dislocation2
- Bone Fracture(s)1
- Insufficient Information1
- Joint Laxity1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 16, 2022Naturally Worn; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT DISLOCATED AND POSSIBLE WORN LINER.
Patient problems: Joint Dislocation
MAUDE report 13542109 ↗InjuryAug 27, 2021Break
SECOND REVISION SURGERY - THE PATIENT HAD DISLOCATED AND HAD A SMALL FRACTURE. THE RIM OF THE LINER HAD BROKEN INTO PIECES. REPRESENTATIVE CONFIRMED THAT ALL BROKEN PIECES WERE REMOVED.
Patient problems: Bone Fracture(s); Joint Dislocation
MAUDE report 12380095 ↗InjuryJul 27, 2021Break; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - LINER BROKE AND LOCKING RING FELL OFF. LINER AND LOCKING RING REPLACED.
Patient problems: Insufficient Information
MAUDE report 12234674 ↗
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