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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; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 623-10-32E
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2019
Event Type  malfunction  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
The customer reported that he had implanted a tritanium primary shell and when tried to impact the 32 10 degree trident liner into the shell, it wouldn't lock in.Another device was opened to complete the case.There was a surgical delay of a few minutes.
 
Manufacturer Narrative
An event regarding seating/locking issue involving a trident liner was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: examination of the returned device by an engineer noted the following: damage observed on outer rim of insert consistent with implantation and explantation process.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional inspection: not performed as the device was returned damaged.Functional inspection: not performed as the device was returned damaged.Material analysis: examination of the returned device by an engineer noted the following: damage observed on outer rim of insert consistent with implantation and explantation process.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: not performed as no medical information was received.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there were no other events for the lot provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information, such as the primary operative report, are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
The customer reported that he had implanted a tritanium primary shell and when tried to impact the 32 10 degree trident liner into the shell, it wouldn't lock in.Another device was opened to complete the case.There was a surgical delay of a few minutes.**update** surgical delay of 2minutes.
 
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Brand Name
TRIDENT 10° X3 INSERT 32MM 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 Key8606136
MDR Text Key144985625
Report Number0002249697-2019-01927
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327039856
UDI-Public07613327039856
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 11/04/2019
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 Date01/31/2024
Device Catalogue Number623-10-32E
Device Lot NumberWP6XT6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2019
Initial Date Manufacturer Received 04/16/2019
Initial Date FDA Received05/13/2019
Supplement Dates Manufacturer Received10/09/2019
Supplement Dates FDA Received11/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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