Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 22E; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 22E; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 690-00-22E
Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)
Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2016
Event Type  Injury  
Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and if received, will be provided in the supplemental report.Not returned to manufacturer.
 
Event Description
It was reported that patient was revised due to a broken constrained liner locking ring (patient did not dislocate).Patient presented to doctor for follow up appointment and broken locking ring was discovered on x-ray.Upon revision, it was noted that patient was impinging and surgeon replaced all hip components.
 
Manufacturer Narrative
An event regarding crack/fracture involving an trident liner was reported.The event was confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: the provided medical records and x-rays were reviewed by a consulting clinician who indicated: "the primary harm involved is mechanical failure of the locking ring in a constrained acetabular liner of a tha." -device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: a review of the provided medical records and x-rays by a clinical consultant indicated: "the primary harm involved is mechanical failure of the locking ring in a constrained acetabular liner of a tha." the exact cause of the event could not be determined because insufficient information was provided.No further investigation for this event is possible at this time.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
 
Event Description
It was reported that patient was revised due to a broken constrained liner locking ring (patient did not dislocate).Patient presented to doctor for follow up appointment and broken locking ring was discovered on x-ray.Upon revision, it was noted that patient was impinging and surgeon replaced all hip components.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRIDENT 0 DEG CONSTRAINED INSERT 22E
Type of Device
PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
rita intorrella
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5514627
MDR Text Key40830421
Report Number0002249697-2016-00952
Device Sequence Number1
Product Code KWZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2020
Device Catalogue Number690-00-22E
Device Lot Number7518W1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age45 YR
-
-