Catalog Number UNK_SHC |
Device Problems
Material Deformation (2976); Noise, Audible (3273)
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Patient Problems
Pain (1994); Injury (2348); Reaction (2414)
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Event Date 12/05/2016 |
Event Type
Injury
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Manufacturer Narrative
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The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
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Event Description
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It was reported through the filing of a lawsuit that allegedly after implantation the patient began experiencing discomfort in the area of his device and developed an audible clunk in his hip when he walked.It is further alleged that initial diagnostic workup revealed gross failure of the accolade trunnion and marked elevation of serum cobalt, chromium and titanium and as a result the patient was forced to have the device surgically removed.
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Manufacturer Narrative
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This event has been identified as a duplicate.Investigation results and conclusions are documented under mfr#0002249697-2015-00789.
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Event Description
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It was reported through the filing of a lawsuit that allegedly after implantation the patient began experiencing discomfort in the area of his device and developed an audible clunk in his hip when he walked.It is further alleged that initial diagnostic workup revealed gross failure of the accolade trunnion and marked elevation of serum cobalt, chromium and titanium and as a result the patient was forced to have the device surgically removed.
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Search Alerts/Recalls
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