TRIDENT II 702-11-48DRecalls & reported problems
Howmedica Osteonics Corp. · Trident II Clusterhole HA Acetabular shell 48D · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327380903), received between Jan 2, 2020 and Jun 23, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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-1622-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Difficult to Setup or Prepare1
- Unstable1
Patient problems
- Joint Laxity1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 23, 2023Unstable; Unstable
UNSTABLE TOTAL RIGHT HIP . REPLACED CUP, POLY LINER, SCREWS , AND FEMORAL HEAD. FEMORAL HEAD WAS COMPETITOR.
Patient problems: Joint Laxity
MAUDE report 17189401 ↗MalfunctionJan 2, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT AFTER IMPACTING THE SHELL, THE IMPACTING BOLT WAS COLD-WELDED INTO THE SHELL AND COULD NOT BE REMOVED. THE CONSTRUCT WAS REMOVED AND ANOTHER SHELL IMPLANTED WITH A SCREW. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10 MINUTES. THE COLD-WELDED CONSTRUCT IS ALLEGEDLY AVAILABLE FOR RETURN. THE REP PROVIDED THE USAGE SHEET SHOWING THE WASTED SHELL AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9538435 ↗
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 · 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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