Trident 643-00-36ERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327025064), received between Feb 24, 2017 and Jun 24, 2022 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K033716); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S LEFT HIP DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. REP PROVIDED USAGE SHEETS FROM THE PRIMARY AND PRIOR REVISION. REP CONFIRMED THAT EXPLANT PICTURES CAN BE PROVIDED AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 14797190 ↗
• InjuryDec 16, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2008 AND WAS REVISED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICES AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF COBALT AND CHROMIUM IN HIS BLOOD. UPDATE PER CLINICIAN REVIEW: "A REVISION SURGERY WAS PERFORMED. METALLOSIS, FRACTURE OF THE FEMORAL STEM AND EXTENSIVE DESTRUCTION OF THE POLYETHYLENE AND LOCKING MECHANISM WERE NOTED."

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology

  MAUDE report 13017971 ↗
• InjuryApr 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT LEG WAS AMPUTATED AND ACETABULAR COMPONENTS REMOVED. PATIENT DEVELOPED AN INFECTION FROM AN ABOVE-THE-KNEE AMPUTATION SITE WHICH WAS PERFORMED (B)(6) 2018. THE INFECTION SPREAD UP THE LEG AND INTO THE HIP. SURGEON PERFORMED A DISARTICULATION OF THE REMAINDER OF THE PATIENT'S LEG (AMPUTATION UP TO THE PELVIS) AND REMOVED THE PATIENT'S ACETABULAR COMPONENTS. A SHELL AND LINER IMPLANTED (B)(6) 2017 WERE REMOVED, AND A RESTORATION MODULAR STEM CONSTRUCT, 36 +0 LFIT HEAD, AND 6 SETS OF DALL-MILES CABLES WERE REMOVED WITH THE REMAINDER OF THE PATIENT'S LEG. REP PROVIDED USAGE REPORTS FOR THE PRIMARY IMPLANTATION AND PRIOR REVISION (PI (B)(6)), AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9996414 ↗
• InjuryFeb 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION OF THE FEMORAL HEAD FROM THE POLY LINER. THE HEAD AND LINER WERE REVISED, AND THE SHELL WAS REVISED IN ORDER TO CHANGE ITS POSITIONING. REP PROVIDED PRIMARY AND REVISION USAGE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9746614 ↗
• InjuryOct 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO RECURRENT DISLOCATIONS. SURGEON REPORTED COMPLICATING FACTORS AS PATIENT EMACIATION WITH VIRTUALLY NO MUSCLE, AND PATIENT NON- COMPLIANCE IN TERMS OF FOLLOW-UP VISITS. PATIENT'S POLY INSERT AND FEMORAL HEAD WERE REVISED TO AN ADM/ MDM LINER CONSTRUCT WITH A 28 +4 LFIT V40 HEAD. REP PROVIDED A WEBOPS REPORT, X-RAY, AND REVISION USAGE SHEET, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Injury; Joint Dislocation

  MAUDE report 9213364 ↗
• InjuryNov 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION (INFECTION REPORTED BY SURGEON. UNKNOWN IF CLINICALLY CONFIRMED, INFECTING MICROORGANISM NOT REPORTED). A HEAD AND LINER EXCHANGE WAS PERFORMED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8092532 ↗
• MalfunctionAug 11, 2017Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT BOTH LAYERS OF STERILE PACKAGING PEELED SIMULTANEOUSLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6788752 ↗
• InjuryFeb 24, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS DISLOCATING. TOTAL HIP WAS CONVERTED TO A MDM CONSTRUCT.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 6356961 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033716. One submission often covers many models, so check the product and lot details in each record.

• Z-2810-2015 · Jun 25, 2015 · Terminated
  Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
• Z-0909-2010 · Feb 17, 2006 · Terminated
  Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes, Mahwah, NJ. Intended for use in cementless fixation fro use in total hip arthroplasty to