Model Number N/A |
Device Problems
Loss of Osseointegration (2408); Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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Cmp-(b)(4).Concomitant medical products: unknown, unknown cup, unknown.Unknown, unknown liner, unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017- 08466, 0001822565-2017-08467.
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Event Description
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It was reported that a patient underwent hip arthroplasty.Subsequently, the patient is being considered for a revision on an unknown day due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) 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.
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Manufacturer Narrative
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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 a patient underwent hip arthroplasty on an unknown date.Subsequently, the patient was revised due to loosening.
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Search Alerts/Recalls
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