Model Number N/A |
Device Problems
Fracture (1260); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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.
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Event Description
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It was reported the g7 curved impactor was damaged in a previous case.The tip is damaged and let the threads past it to engage into the shell.There was no patient involvement.It was reported that no further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the are large gouges on the tip of the inserter.It is unknown if they are fractured pieces or deformation of the material based on the provided image.Lot identification is necessary for review of device history records, lot identification was not provided.Medical records were not provided.A definitive root cause cannot 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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