Model Number N/A |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Code Available (3191)
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Event Date 05/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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 during trialing a modular box provisional was proud by at least 6mm.The box could not be cut deeper so two 5mm distal augments were placed.A delay of sixty to ninety minutes occurred.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional 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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This follow-up is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated report: 0001822565-2019-01735.Medical product unknown nexgen instrument.Reported event was unable to be confirmed as no devices were received; therefore, the condition of the components is unknown.Photographs provided of the device show evidence of minor wear.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot 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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It was reported that during trialing a modular box provisional was seating proud.The box could not be cut deeper so two distal augments implants were used to complete the procedure.It was noted that the chaffer cuts were off now.A delay of sixty to ninety minutes occurred.No additional information is available.
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Search Alerts/Recalls
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