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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 623-00-36E
Device Problems Device Dislodged or Dislocated (2923); Material Distortion (2977); Scratched Material (3020)
Patient Problems Injury (2348); Joint Dislocation (2374)
Event Date 11/14/2017
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was reported that patient's left hip was revised.Patient reported a dislocation, surgeon had planned to swap out liner for mdm but while removing ceramic head from stem the stem came loose.Also, surgeon noticed a roughened articular surface on the poly liner and thought it was out of the ordinary.
 
Manufacturer Narrative
Additional information: date of implant.An event regarding dislocation involving a trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: a material analysis has been performed.The report concluded: ¿scratching was observed on along the body of the hip stem.A continuous metal transfer ring was observed on the internal circumference of the female taper consistent with proper seating between of the trunnion of the hip stem and the head taper.Scratching, pitting and embedded debris were observed on the surfaces of the trident insert.Eds showed that the hip stem was consistent with astm f136 and the adhered debris on the trident insert was consistent with a bone fragment.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined." -medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: the material analysis reported concluded that "scratching was observed on along the body of the hip stem.A continuous metal transfer ring was observed on the internal circumference of the female taper consistent with proper seating between of the trunnion of the hip stem and the head taper.Scratching, pitting and embedded debris were observed on the surfaces of the trident insert.Eds showed that the hip stem was consistent with astm f136 and the adhered debris on the trident insert was consistent with a bone fragment.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined." therefore the event of trident liner dislocation was not confirmed.Further information such as patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information becomes available, this investigation will be reopened.
 
Event Description
It was reported that patient's left hip was revised.Patient reported a dislocation, surgeon had planned to swap out liner for mdm but while removing ceramic head from stem the stem came loose.Also, surgeon noticed a roughened articular surface on the poly liner and thought it was out of the ordinary.
 
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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 Key7105056
MDR Text Key94423302
Report Number0002249697-2017-03547
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327039542
UDI-Public07613327039542
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 02/09/2018
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 Date09/18/2022
Device Catalogue Number623-00-36E
Device Lot Number207VA1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2017
Initial Date Manufacturer Received 11/14/2017
Initial Date FDA Received12/11/2017
Supplement Dates Manufacturer Received01/12/2018
Supplement Dates FDA Received02/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age67 YR
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