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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 32MM ID IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 32MM ID IMPLANT Back to Search Results
Catalog Number 623-00-32E
Device Problems Mechanical Problem; Difficult To Position; Mechanics Altered; Positioning Problem
Event Date 07/13/2015
Event Type  Malfunction  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

It was reported that the insert could not be locked with the cup during tha. So, spare insert was used instead of it.

 
Manufacturer Narrative

An event regarding the inability of an insert to lock into a shell involving a trident 0° x3 insert 32mm id was reported. The event was not confirmed. Method & results: -device evaluation and results: the liner was returned with various scratches and indentations consistent with an unsuccessful impaction. Although the exact cause of the device not being locked into the shell can not be determined, there were several indentations that are consistent with the insert being impacted with the indexing barbs on the shell not being completely aligned with the insert's final locking position. Also there was indentations on the insert's locking ring which also suggests it was impacted while the liner was not fully positioned. Whether this damage occurred during the initial attempt at impacting the liner or during subsequent attempts can not be determined. A dimensional and functional inspection could not be performed as the device was returned in a damaged condition. -medical records received and evaluation: not performed as no clinical information was provided as there is no indication that the event is related to patient factors. -device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies. -complaint history review: there have been no other similar events reported for this manufacturing lot. Conclusions: the investigation concluded that the exact cause of the event could not be determined due to the device being returned in a damaged condition. However there were several indentations that are consistent with the insert being impacted with the indexing barbs on the shell not being completely aligned with the insert's final locking position. Also there was indentations on the insert's locking ring which also suggests it was impacted while the liner was not fully positioned. Whether this damage occurred during the initial attempt at impacting the liner or during subsequent attempts can not be determined. It was also concluded that there is no indication the event is related to a manufacturing issue. No further investigation for this event is possible at this time. If additional information become available, this investigation will be reopened.

 
Event Description

It was reported that the insert could not be locked with the cup during tha. So, spare insert was used instead of it.

 
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Brand NameTRIDENT 0° X3 INSERT 32MM 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 Key5024928
Report Number0002249697-2015-02747
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2020
Device Catalogue Number623-00-32E
Device LOT NumberH30N79
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/07/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/01/2015
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: 08/24/2015 Patient Sequence Number: 1
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