Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
No Information (3190); Insufficient Information (4580)
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Event Date 12/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the patients legal counsel did not approve of the return.The investigation is in process and a follow-up mdr will be submitted upon completion.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00047, 0001825034 - 2021 - 00048, 0001825034 - 2021 - 00050.
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Event Description
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It was reported that patient underwent a hip revision after an unknown amount of time post implantation due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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 that patient underwent a left hip revision approximately 13 years post implantation due to unknown reasons.During the procedure, all components were removed from the patient due to failed metal on metal implant.Attempts have been made and additional information is unavailable at this time.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information provided by the customer.Visual examination of the pictures shows the stem, taper and head are all assembled and shows scaring on the stem typical of a product being implanted and removed.Dhr was unable to be reviewed as the lot number for the device is unknown.The root cause is unable to be determined.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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No further event information available at the time of this report.
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Manufacturer Narrative
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Upon reassessment of the additional information, it was found that this device did not contribute to the reported event and is therefore, not reportable.
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Event Description
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Upon reassessment of the additional information, it was found that this device did not contribute to the reported event and is therefore, not reportable.
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Search Alerts/Recalls
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