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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 623-00-36F
Device Problem Scratched Material (3020)
Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Event Date 02/22/2019
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation.A 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.
 
Event Description
Revision hip due to pain.Primary hip replacement (b)(6) 2018.Polyethylene liner found to have small metal looking scratches on inner surface.Metal head has scratched surface too.Bone screws were also loose and cup had very minimal on growth of bone.All acetabular components removed.Acetabulum revised using competitor prosthesis.
 
Manufacturer Narrative
An event regarding wear and damage involving a trident liner was reported.The event was confirmed following review of provided photographs.Method & results: device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted liner with wear and damaged evident.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.A review of the provided medical records and x-rays by a clinical consultant indicated: "provided x-ray does not confirm the reported event.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components." -device history review: all devices 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.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports and return of the device are needed to fully investigate the event.If further information becomes available and/or the product is returned, this investigation will be re-opened.
 
Event Description
Revision hip due to pain.Primary hip replacement (b)(6) 2018.Polyethylene liner found to have small metal looking scratches on inner surface.Metal head has scratched surface too.Bone screws were also loose and cup had very minimal on growth of bone.All acetabular components removed.Acetabulum revised using competitor prosthesis.
 
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Brand Name
TRIDENT 0° 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 Key8443605
MDR Text Key139555576
Report Number0002249697-2019-01417
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327039535
UDI-Public07613327039535
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 05/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/29/2020
Device Catalogue Number623-00-36F
Device Lot Number50898301
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/22/2019
Initial Date FDA Received03/22/2019
Supplement Dates Manufacturer Received04/10/2019
Supplement Dates FDA Received05/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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