Trident 621-10-28ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327037739), received between Nov 10, 2023 and Nov 10, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Unstable” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K983382, K983502); they may or may not involve this specific model.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2023Unstable; Unstable

  THIS PI IS FOR THE 1ST REVISION. PER MEDICAL RECORDS RECEIVED FOR PI: "SHE HAD A THA DONE IN 2004. THIS SUBSEQUENTLY HAD ISSUES WITH INSTABILITY AND WAS REVISED WITH A HEAD AND LINER EXCHANGE IN 2010."

  Patient problems: Joint Laxity

  MAUDE report 18115766 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K983382, K983502. One submission often covers many models, so check the product and lot details in each record.

• Z-3204-2026 · Jul 30, 2026 · Open, Classified
  TRIDENT 0 POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
• Z-1043-2015 · Dec 15, 2014 · Terminated
  Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a s
• Z-0072-2008 · Aug 30, 2007 · Terminated
  Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis component. Howmedica Osteonics Corp. 325 Corporate Drive; Mahwah, NJ 07430;
• Z-0073-2008 · Aug 30, 2007 · Terminated
  HA Solid Back Acetabular Shell; Arc Deposited HA Coated Included Dome hole Plug; Hip prosthesis component. Sterile; made in USA; Howmedica Osteonics Corp.; 325 Corporate Drive; M
• Z-1261-2007 · Mar 13, 2006 · Terminated
  Trident PSL Acetabular Shell;Arc Deposited;Hydroxylapatite Coated;Cluster Screw Holes;Howmedica Osteonics Corp., 325 Corporate DriveMahway, NJ 07430