STRYKER ORTHOPAEDICS-MAHWAH 28MM -4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 6260-5-028 |
Device Problems
Material Deformation (2976); Scratched Material (3020); Insufficient Information (3190)
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Patient Problems
Edema (1820); Injury (2348); Peroneal Nerve Palsy (2362); Osteolysis (2377)
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Event Date 02/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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On (b)(6) 2018, the patient underwent tha revision surgery.The initial tha surgery was performed with super secure fit and v40 taper vit head on (b)(6) 2006.The patient complained symptom of femoral nerve palsy in 2017, and mri showed pseudo tumor and osteolysis.In the revision surgery, some black foreign material noted near the junction (including inside of the head) of the head and neck.Ultimately, the head and a liner was replaced with new ones and the revision surgery was completed.
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Event Description
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On (b)(6) 2018, the patient underwent tha revision surgery.The initial tha surgery was performed with super secure fit and v40 taper vit head on 10/16/2006.The patient complained symptom of femoral nerve palsy in 2017, and mri showed pseudo tumor and osteolysis.In the revision surgery, some black foreign material noted near the junction (including inside of the head) of the head and neck.Ultimately, the head and a liner was replaced with new ones and the revision surgery was completed.
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Manufacturer Narrative
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An event regarding wear and altr involving a metal head was reported.The event (wear) was confirmed through the material analysis report.Altr was not confirmed.Method & results: -device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated 23 april 2018.Images of the device are included in the mar.Scratches and damages consistent with the explantation process were observed on the femoral head.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed because the event is related to in-vivo performance and therefore functionality could not be duplicated.Material analysis: a material analysis has been performed.The report concluded: burnishing, scratching, third body indentations, and explantation damage were observed on the acetabular insert.Eds showed that the femoral head was consistent with astm f1537.The adhered debris on the femoral head was consistent with biological debris and cleaning.The debris material from the metal head/stem was consistent with biological material.Based on the given information, no identifiable material or manufacturing discrepancies were observed.-medical records received and evaluation: no medical records were received for review with a clinical consultant -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, histopathology report, progress notes and x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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