Model Number N/A |
Device Problem
Break (1069)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 04/18/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.Concomitant medical products: medical product: unknown oxford bearing s4 catalog #: not reported lot #: not reported, medical product: unknown oxford femoral component s l catalog #: not reported lot #: not reported.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00692, 3002806535-2019-00691.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 an initial left knee replacement surgery.Subsequently, a revision procedure was performed due to progression of oa and pain.During operation bearing was found to be fractured with metallosis in the joint.
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Manufacturer Narrative
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(b)(4).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 has been reported by the hospital that a patient underwent an initial left knee replacement surgery.Subsequently, a revision procedure was performed due to progression of oa and pain.During operation bearing was found to be fractured with metallosis in the joint.
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Search Alerts/Recalls
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