Catalog Number 502-01-60G |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/09/2014 |
Event Type
Injury
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Event Description
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It was reported that patient had right hip revised due to loose acetabular shell.
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available, the evaluation summary will be submitted in a supplemental report.(b)(4) retained.
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Manufacturer Narrative
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The patient is (b)(6) in height.An event regarding loosening involving a trident shell was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a medical review was not performed because insufficient information was provided.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.
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Event Description
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It was reported that patient had right hip revised due to loose acetabular shell.
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Search Alerts/Recalls
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