Trident 621-10-26FRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327037692), received between Jun 5, 2020 and Jun 5, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (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 16, 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.

• InjuryJun 5, 2020Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  THE CLEAR ZONE WAS CONFIRMED IN 2016 AND REVISION SURGERY OF LINER WAS DONE (B)(6) 2020. THE DATE OF THE PRIMARY SURGERY IS BEING CONFIRMED. THE DOCTOR REQUESTED AN INVESTIGATION OF THE AMOUNT OF WEAR ON THE LINER.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10122662 ↗

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-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-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-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