Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Dob: unknown date in 1956.Foreign country: (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.
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Event Description
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It was reported the surgeon was unable to break into stability when he cracked down on the lining.It was not possible to step down at the time, and was only able to implant ceramic linings later.Attempts have been made and no further information has been provided.
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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.Reported event was unable to be confirmed due to limited information received from the customer.Device was returned and evaluated.Upon visual inspection the device has multiple circular indentations on the outer radius.The locking feature and the scallops show no damage.No further measurements were taken due to impaction.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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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Search Alerts/Recalls
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