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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID IMPLANT Back to Search Results
Catalog Number 623-00-36H
Device Problems Unstable (1667); Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)
Patient Problems Injury (2348); Joint Dislocation (2374); No Code Available (3191)
Event Date 07/07/2015
Event Type  Injury  
Event Description

It was reported that patient's left hip was revised due to instability and dislocation.

 
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Should additional information become available it will be reported in a supplemental report.

 
Manufacturer Narrative

An event regarding dislocation involving a trident liner was reported. The event was not confirmed. Method & results: -device evaluation and results: not performed as no device was returned for evaluation. -medical records received and evaluation: not performed as patient medical records were not provided for review. -device history review: all devices accepted into final stock conformed to specification. -complaint history review: there have been no similar previous reported events for this lot id. Conclusions: the exact cause of the event could not be determined because no patient medical records were provided for review and the device was not returned for evaluation. No further investigation for this event is possible at this time. If devices and/or additional information become available, this investigation will be reopened.

 
Event Description

It was reported that patient's left hip was revised due to instability and dislocation.

 
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Brand NameTRIDENT 0° X3 INSERT 36MM ID
Type of DeviceIMPLANT
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
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4950659
MDR Text Key6192557
Report Number0002249697-2015-02505
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK033716
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,HEALTH PROFESSIONAL,OTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/07/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2019
Device Catalogue Number623-00-36H
Device LOT NumberMMTH1D
OTHER Device ID NumberSTERILE LOT# MSGNA05D5
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/07/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/29/2015 Patient Sequence Number: 1
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