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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 Difficult to Insert; Mechanical Problem; Mechanics Altered; Positioning Problem
Event Date 08/04/2015
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

During a primary left hip procedure. Surgeon attempted to seat and lock in liner but after three attempts was unsuccessful in getting the liner to seat and lock. Surgeon stated no soft tissue was in the way of the liner and sales rep retrieved another liner of same catalog number and size, provided to surgeon to complete the case. Surgical delay of ten minutes as a result of three tries to seat/lock the liner and to retrieve a new liner from stock by sales rep.

 
Manufacturer Narrative

An event regarding seating locking issue 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 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

During a primary left hip procedure. Surgeon attempted to seat and lock in liner but after three attempts was unsuccessful in getting the liner to seat and lock. Surgeon stated no soft tissue was in the way of the liner and sales rep retrieved another liner of same catalog number and size, provided to surgeon to complete the case. Surgical delay of ten minutes as a result of three tries to seat/lock the liner and to retrieve a new liner from stock by sales rep.

 
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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 Key5042092
Report Number0002249697-2015-02843
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/04/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2019
Device Catalogue Number623-10-32F
Device LOT NumberP08X7L
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/12/2014
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: 08/31/2015 Patient Sequence Number: 1
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