STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
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Catalog Number 625-0T-32F |
Device Problem
Noise, Audible (3273)
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Patient Problems
Pain (1994); Injury (2348)
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Event Date 09/17/2018 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding audible noise & pain involving a trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including lot details, progress notes, x-rays and return of the device 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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Event Description
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Surgeon removed a ceramic head and ceramic liner and replaced with a universal biolox head and polyethylene liner.Implants that were not removed are as follows: 6021-0435, lot 13131801.542-11-54f, lot 31334103.Update 19/september/2018: as reported in how was issue noticed: patient had pain and heard a clicking.No problems were evident upon visual examination of the removed components.
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Search Alerts/Recalls
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