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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; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 623-10-36G
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/17/2018
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
 
Event Description
Surgeon tried to fit a trident 10 degree liner (x3) into trident cup.Would not sit, regardless of troubleshooting.New liner sat perfectly first time.
 
Event Description
Surgeon tried to fit a trident 10 degree liner (x3) into trident cup.Would not sit, regardless of troubleshooting.New liner sat perfectly first time.
 
Manufacturer Narrative
An event regarding seating/locking issue involving a trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection visual inspection was performed as part of the material evaluation and indicated the following comments: damage observed on insert consistent with attempted implantation dimensional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Functional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis: material evaluation was completed and indicated the following comments: ma: damage observed on insert consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.- medical records received and evaluation: no medical records were received for review with a clinical consultant.- device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.- complaint history review: there have been no other similar events for the reported lot.Conclusions: material evaluation was completed and indicated the following comments: damage observed on insert consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.However, the exact cause of the event cannot be determined based on the information provided.Further information such as operative report are 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 and/or the device becomes available the investigation will be reopened.
 
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Brand Name
TRIDENT 10° X3 INSERT 36MM ID
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8245315
MDR Text Key132975989
Report Number0002249697-2019-00169
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327039931
UDI-Public07613327039931
Combination Product (y/n)N
PMA/PMN Number
K033716
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 04/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2022
Device Catalogue Number623-10-36G
Device Lot NumberJ0332P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2019
Initial Date Manufacturer Received 12/17/2018
Initial Date FDA Received01/14/2019
Supplement Dates Manufacturer Received04/02/2019
Supplement Dates FDA Received04/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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