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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 36MM IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 36MM IMPLANT Back to Search Results
Catalog Number 623-00-36D
Device Problems Use of Device Problem; Fitting Problem; Mechanics Altered; Misassembly by Users
Event Date 05/28/2015
Event Type  Malfunction  
Event Description

The customer reported that when the surgeon was implanting a trident liner, the device allegedly appeared to be misshapen and did not fit the trident shell. The customer further reported that another device (same product code and lot number) was used to complete the case and that did fit the shell. Opening a second device resulted in a 10 minute delay to surgery. There were no other adverse consequences for the patient.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Review of device history records indicates the lot was manufactured and accepted into final stock. There have been no other events for the lot referenced. 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. 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

The customer reported that when the surgeon was implanting a trident liner, the device allegedly appeared to be misshapen and did not fit the trident shell. The customer further reported that another device (same product code and lot number) was used to complete the case and that did fit the shell. Opening a second device resulted in a 10 minute delay to surgery. There were no other adverse consequences for the patient.

 
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Brand NameTRIDENT 0 DEG INSERT 36MM
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
keyla navedo
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key4878840
Report Number0002249697-2015-02135
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 06/04/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2019
Device Catalogue Number623-00-36D
Device LOT NumberMNNV1M
OTHER Device ID NumberSTERILE LOT# MSGNN23J7
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/16/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/25/2014
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: 06/30/2015 Patient Sequence Number: 1
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