Model Number N/A |
Device Problem
Break (1069)
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Patient Problem
Bone Fracture(s) (1870)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).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 was reported that a patient underwent an initial knee replacement procedure.Subsequently, a revision procedure due to bearing fracture was performed.
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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 was reported that a patient underwent an initial knee replacement procedure.Subsequently, a revision procedure due to bearing fracture was performed.Patient received left side, cementless medial oxford partial knee.
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Event Description
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It was reported that a patient underwent an initial knee replacement procedure.Subsequently, a revision procedure due to bearing fracture was performed.Patient received left side, cementless medial oxford partial knee.
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Manufacturer Narrative
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This follow-up report is being submitted to relay corrected 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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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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Event Description
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It was reported that a patient underwent an initial knee replacement procedure.Subsequently, a revision procedure due to bearing fracture was performed.
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Search Alerts/Recalls
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