Catalog Number 00801803202 |
Device Problem
Off-Label Use (1494)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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This report was previously submitted under medwatch 1822565-2015-00202.This report will be amended when our investigation is complete.
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Event Description
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It is reported that the pt underwent a revision due to a mismatch of the femoral head.The surgeon feels that the lettering on the implants is unclear.
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Manufacturer Narrative
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This report was previously submitted under medwatch 1822565-2015-00202.This report will be amended when our investigation is complete.
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Event Description
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It is reported that the patient underwent a revision due to a mismatch of the femoral head.The surgeon feels that the lettering on the implants is unclear.
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Manufacturer Narrative
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This (b)(4) design-controlled device was used for treatment.No devices or associated packaging was returned for further evaluation.Device history records for lot code associated with the reported device were reviewed.No deviations or anomalies were noted with the associated labeling.The device was manufactured, inspected and packaged to specification.The original labels issued for this device were reviewed and confirmed to be legible.The femoral head and liner are etched with the product size specification.This assists in verifying that the appropriate size is present in the box and implanted with identical pairing of devices.
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Search Alerts/Recalls
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