Model Number N/A |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source - foreign: (b)(6).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the surgeon identified damage on the surface of the implant prior to implanting it and opted not to use the device.Another device was used to complete the procedure.No adverse events were reported as a result of this event.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was confirmed through visual inspection.The returned articular surface exhibited nicks, gouges and scratches on the surface.The device history records were reviewed and no discrepancies relevant to the reported event were identified.A definitive root cause could not be determined with the information 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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Event Description
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No further event information available at the time of this report.
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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; g3; g4; g6; h1; h2
upon reassessment of the reported event, it was determined to no longer be reportable as there no serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial reports should be voided.
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Event Description
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Upon reassessment of the reported event, it was determined to no longer be reportable as there no serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial reports should be voided.No new reports will be submitted under biomet as the event is not reportable.
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Search Alerts/Recalls
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