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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 623-10-32G
Device Problems Mechanics Altered; Adverse Event Without Identified Device or Use Problem
Event Date 05/11/2015
Event Type  Malfunction  
Event Description

It was reported, "that the insert (623-10-32g) did not locked the cup (542-11-58g) during medical procedure. So, another insert was implanted and it could be locked. ".

 
Manufacturer Narrative

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

 
Manufacturer Narrative

An event regarding seating/locking issues involving a trident liner was reported. The event was not confirmed. Method & results: -device evaluation and results: the device was returned for analysis, scratching and damage was identified around the locking tab of the polyethylene insert consistent with attempts of implantation. Dimensional inspection: the device was within specification except feature 16 which is consistent with damage due attempted implantation. Functional inspection: not performed due to the damage identified in the visual inspection. -medical records received and evaluation: a medical review was not performed because insufficient information was provided. -device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies. -complaint history review: review indicated there have been no other events for the reported lot. Conclusions: the device was returned for analysis. Damage was identified around the locking tab of the polyethylene insert consistent with implantation attempts. There was no evidence of a dimensional issue on review of the device history record and no other events for the same lot have been reported. However, the exact cause of the event cannot be determined based on the information provided. Further information such as the operative report is needed to complete the investigation for determining root cause. No further investigation is possible at this time as insufficient information was received. If additional information becomes available the investigation will be reopened.

 
Event Description

It was reported, "that the insert (623-10-32g) did not locked the cup (542-11-58g) during medical procedure. So, another insert was implanted and it could be locked. ".

 
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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-CORK
ida industrial estate
carrigtwohill NJ NA
Manufacturer Contact
beverly lima
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key4825285
Report Number0002249697-2015-01821
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 05/11/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/08/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2015
Device Catalogue Number623-10-32G
Device LOT Number34692901
OTHER Device ID NumberSTERILE LOT# 1008V292
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/14/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/02/2010
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: 06/08/2015 Patient Sequence Number: 1
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