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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID IMPLANT Back to Search Results
Catalog Number 623-10-32F
Device Problems Use of Device Problem; Mechanics Altered; Misassembly by Users
Event Date 05/21/2015
Event Type  Malfunction  
Event Description

It was reported that the insert could not be locked with the cup during medical procedure. A spare insert was used and the procedure was completed.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

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 that the insert could not be locked with the cup during medical procedure. A spare insert was used and the procedure was completed.

 
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Brand NameTRIDENT 10° 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 Key4854054
Report Number0002249697-2015-01998
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type Other,Health Professional,HEALTH PROFESSIONAL,OTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/25/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/18/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2019
Device Catalogue Number623-10-32F
Device LOT NumberMNJE0L
OTHER Device ID NumberSTERILE LOT# MSGNK10J7
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/12/2014
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: 06/18/2015 Patient Sequence Number: 1
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