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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 542-11-50E
Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Patient Problem Injury (2348)
Event Date 11/29/2018
Event Type  Injury  
Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.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
It was reported that tha was done with trident ha shell and x3 liner and stem.The shell was dislocated in about one year after tha.Therefore, all devices were removed and revision surgery was done.The removed polyethylene liner was yellowish discolored.Update dec 17, 2018- cause of revision shell was dislocated (malposition).
 
Manufacturer Narrative
An event regarding loosening involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device noted the following: the shell was returned with the liner locked into it and with the fixation screw protruding through the screw hole.Ha coating is still present on the outer surface and there is some areas with slight bony ingrowth.Apart from this, the shell and screw appear unremarkable.-medical records received and evaluation: not performed as no medical information was received for review 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 have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
It was reported that tha was done with trident ha shell and x3 liner and stem.The shell was dislocated in about one year after tha.Therefore, all devices were removed and revision surgery was done.The removed polyethylene liner was yellowish discolored.Update dec 17, 2018- cause of revision shell was dislocated (malposition).
 
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Brand Name
TRIDENT PSL HA CLUSTER 50MM
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 Key8203902
MDR Text Key131643648
Report Number0002249697-2018-04161
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327037265
UDI-Public07613327037265
Combination Product (y/n)N
PMA/PMN Number
K143085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 03/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Catalogue Number542-11-50E
Device Lot Number61473503
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2019
Date Manufacturer Received02/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age81 YR
Patient Weight40
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