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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; IMPLANT Back to Search Results
Catalog Number 623-10-36G
Device Problems Use of Device Problem (1670); Mechanics Altered (2984); Misassembly by Users (3133)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/24/2015
Event Type  malfunction  
Event Description
It was reported, "a 36mm 10degree x3 trident liner did not lock into trident psl acetabular cup.Multiple attempts were made to introduce and lock liner into the cup.Surgeon then made the decision to put in another (backup) liner.Secondary liner locked into the cup on the first attempt.No visual impairments noted with cup prior to insertion.Only after multiple insertion attempts was it identified.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
Reported event: an event regarding seating locking involving a trident 10° x3 insert was reported.The event was confirmed.Method & results: device evaluation and results: the subject liner was returned in used condition with damages consistent with the reported implantation attempt.Minor indentation damage is noted all around the back side of the device on both the hemispherical surface and the locking face.This damage appears consistent with debris trapped between the liner and shell.Medical records received and evaluation: medical records or x-rays were not provided for analysis.Device history review: review of the device history records indicate that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation determined the likely root cause of the event to be debris trapped between the mating faces of the liner and shell during insertion and attempted locking.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.
 
Event Description
It was reported, "a 36mm 10degree x3 trident liner did not lock into trident psl acetabular cup.Multiple attempts were made to introduce and lock liner into the cup.Surgeon then made the decision to put in another (backup) liner.Secondary liner locked into the cup on the first attempt.No visual impairments noted with cup prior to insertion.Only after multiple insertion attempts was it identified.
 
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Brand Name
TRIDENT 10° X3 INSERT 36MM ID
Type of Device
IMPLANT
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 Key4621276
MDR Text Key5655426
Report Number0002249697-2015-00825
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033716
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,health professional,oth
Reporter Occupation Other
Type of Report Initial
Report Date 02/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2018
Device Catalogue Number623-10-36G
Device Lot NumberMMPXT5
Other Device ID NumberSTERILE LOT# MSGMP28E5
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received08/04/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/30/2013
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;
Patient Age59 YR
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