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 10° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  • 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 10° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 623-10-32D
Device Problems Material Deformation (2976); Material Integrity Problem (2978); Mechanics Altered (2984)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2017
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that a trident liner would not lock into the acetabular cup.They had to open a second which then locked in perfectly.Delay only trying to get liner to lock with additional impaction attempts and getting additional liner which subsequently seated correctly.This was primary surgery.
 
Manufacturer Narrative
An event regarding seating/locking issues involving a trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection: the returned device was inspected by the manufacturing cell, the device was identified as being oval in shape.The device is otherwise unremarkable.Dimensional inspection: not performed as the device is oval in shape.However a review of original in process inspection was completed by the manufacturing engineer.The device was found to be dimensionally within specification as per (b)(4).-medical records received and evaluation: no information was received for review with the clinical consultant.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as patient details, operative reports and x-rays are needed to investigate this event further.If additional information becomes available, this investigation will be reopened.
 
Event Description
The customer reported that a trident liner would not lock into the acetabular cup.They had to open a second which then locked in perfectly.Delay only trying to get liner to lock with additional impaction attempts and getting additional liner which subsequently seated correctly.This was primary surgery.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRIDENT 10° X3 INSERT 32MM ID
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6382368
MDR Text Key69489170
Report Number0002249697-2017-00794
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327039849
UDI-Public(01)07613327039849(11)161110(17)211130(10)57770001
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K033716
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 05/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2021
Device Catalogue Number623-10-32D
Device Lot Number57770001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/08/2017
Initial Date FDA Received03/06/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2016
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) Other;
-
-