Model Number N/A |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 broached with the correct set/sequence of broaches and when implanting the real stem, the implant was too small.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
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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.Device was received and evaluated against the complaint.Product was identified by the etch on the top of the neck.There are no obvious signs of damage or use.There are small areas of discoloration along the porous-coated shaft.No other damage noted.Overall length and width of the product were found to be conforming and within specification.A review of the device history records identified no related deviations or anomalies during manufacturing.A definitive root cause cannot be identified.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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