Model Number N/A |
Device Problem
Break (1069)
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Patient Problem
Fall (1848)
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Event Date 04/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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Event Description
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It has been reported by the hospital that a patient underwent a knee replacement surgery.Subsequently a revision surgery was performed due to bearing fracture following jump from a jeep.Bearing size 3 was exchanged for a size 4.
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Event Description
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It has been reported by the hospital that a patient underwent a knee replacement surgery.Subsequently a revision surgery was performed due to bearing fracture following jump from a jeep.Bearing size 3 was exchanged for a size 4.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.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.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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Search Alerts/Recalls
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