Model Number N/A |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Metal Related Pathology (4530)
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Event Type
Injury
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Manufacturer Narrative
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Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (b)(4) legal department is well trained and passes all information concerning the case to our complaint handling department.As soon as supplemental information becomes available an updated report will be submitted.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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It was reported that: claim for damages allegedly caused by zimmer (b)(4) hip prosthesis implanted to female patient (unknown primary implante date and patient age) at right hip (unknown primary implant date) and revised in (b)(6) 2019 for elevated metal ion levels.Patient outcome - revision.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: the product was not returned for investigation.Therefore, visual and dimensional evaluation could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Device is used for treatment.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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