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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Nerve Damage (1979)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Report source: comparison between simultaneous versus staged bilateral tha in patients with painful disabling hip diseases.A prospective, randomized, controlled study.Dr.(b)(6), dr.(b)(6), dr.(b)(6), and dr.(b)(6).Concomitant medical products: unknown head.Unknown stem.Unknown cup.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02449, 0001822565-2020-02457, 0001822565-2020-02458.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.[comparison between simultaneous versus staged bilateral tha.Pdf].
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Event Description
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It was reported in a journal study that one patient experienced a transient sciatic nerve palsy within 6 months post implantation that was treated medically and completely resolved.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. the following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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.H3 other text : device not returned for evaluation.
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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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