Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 02/19/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported the patient underwent a left hip revision approximately 3 years post implantation due to unknown reasons.No additional information.
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Manufacturer Narrative
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Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
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Event Description
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Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
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Search Alerts/Recalls
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