STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 623-00-36E |
Device Problems
Device Dislodged or Dislocated (2923); Material Distortion (2977); Scratched Material (3020)
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Patient Problems
Injury (2348); Joint Dislocation (2374)
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Event Date 11/14/2017 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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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Manufacturer Narrative
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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.
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Event Description
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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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Search Alerts/Recalls
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