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Model Number N/A |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: bipolar shell, modular 46, item#: 6127004,6 lot#: 3110465.Report source: germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00513.Currently still implanted.
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Event Description
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It was reported that during an op, the inlay was found to be slightly tilted in the shell.The surgeon was able to complete the surgery using these same devices.No patient harm was reported, due diligence is in progress for this event; to date 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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(b)(4).G2- germany: this follow-up report is being submitted to relay additional information.No product was returned, but pictures were provided: review of the pictures was performed.Devices are used for treatment.Review of the manufacturing records shows that all the specifications were met at the moment of production.Product were not returned for investigation, therefore with the available data it is impossible to establish a definitive root cause.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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