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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 623-00-36F
Device Problems Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)
Patient Problems Joint Dislocation (2374); No Code Available (3191)
Event Date 06/15/2015
Event Type  Injury  
Event Description

Patient's primary hip done elsewhere - all (b)(4). Acetabular revision to tritanium shell and liner only. Patient dislocated. Surgeon revised liner to mdm liner and poly. Right hip.

 
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Additional information was requested and if it becomes available will be submitted in a supplemental report. Given to patient.

 
Manufacturer Narrative

Based on the provided information it has been determined that this event is associated with an off-label application. It was reported that a trident shell and liner were implanted with a competitor¿s head. It was then reported this mixed component system dislocated. The reported liner is packaged with instructions for use ((b)(4), rev h) that states, ¿warnings: do not substitute another manufacturer¿s device for any of the howmedica osteonics trident system components because design, material, or tolerance differences may lead to premature device and/or functional failure. Components of the system have been specifically designed to work together. Any such use will negate the responsibility of howmedica osteonics corp. For the performance of the resulting mixed component implant. ¿ no further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

Patient's primary hip done elsewhere - all zimmer. Acetabular revision to tritanium shell and liner only. Patient dislocated. Surgeon revised liner to mdm liner and poly. Right hip.

 
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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 Key4901723
MDR Text Key15970085
Report Number0002249697-2015-02263
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 06/15/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/09/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2019
Device Catalogue Number623-00-36F
Device LOT NumberMNMWHK
OTHER Device ID NumberSTRYKER LOT# MSGNN05J7
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 Received08/03/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/10/2014
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: 07/09/2015 Patient Sequence Number: 1
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