TRIDENT II 702-11-50DRecalls & reported problems
Howmedica Osteonics Corp. · Trident II Clusterhole HA Acetabular shell 50D · Class 2 · Implant
All models of TRIDENT II (42)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327381047), received between Jun 23, 2021 and May 23, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Feb 27, 2024Class IIOpen, Classified
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Z-1623-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Loss of Osseointegration1
- Osseointegration Problem1
- Unstable1
Patient problems
- Ambulation or Postural Difficulties1
- Inadequate Osseointegration1
- Insufficient Information1
- Joint Laxity1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2022Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information
THE SITE INQUIRED IF A PATIENT CAN BE A PART OF THE TRIDENT II REVISION STUDY. HOWEVER, IN DOING SO, THEY MENTIONED THAT THE PATIENT ALREADY HAD A THA WITH TRIDENT II TRITANIUM ACETABULAR SHELL, AND THE SURGEON IS PLANNING TO USE MULTIHOLE INSTEAD OF CLUSTERHOLE THIS TIME. THERE IS NO OTHER INFORMATION AVAILABLE FOR THE PATIENT AT THIS TIME. PROPOSED DATE OF REVISION IS (B)(6) 2022.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Pain
MAUDE report 14468939 ↗InjuryOct 22, 2021Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO ASEPTIC LOOSENING OF THE ACETABULAR SHELL. THE SHELL, A SCREW, HEAD, AND LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Inadequate Osseointegration
MAUDE report 12681979 ↗InjuryJun 23, 2021Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY AND RECURRING DISLOCATIONS. A SHELL, SCREW, POLY LINER AND HEAD WERE REVISED TO A SHELL, SCREW, MDM METAL LINER, ADM/MDM POLY INSERT, AND A NEW HEAD (SHELL WAS REVISED TO CHANGE ITS POSITION). REP PROVIDED PRIMARY AND REVISION USAGE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Joint Laxity
MAUDE report 12047475 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 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 · each recall links to the FDA recall notice
- 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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