Model Number N/A |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/20/2019 |
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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-01545.
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Event Description
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It was reported that during a primary implant surgery the stems were undersized/ smaller than the broach trial.Other stem products were used to complete surgery.Additional information was requested, however no information was available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Udi: (b)(4).Complaint sample was evaluated and the reported event was not confirmed.Two stems were returned and evaluated against the complaint.Visual inspection of each stem, no significant scuffing or scratching was observed for either stem.Both stems were measured to confirm they are consistent stem overall length and ap and ml width of porous coating.Both stems conform to print criteria for identification.The profile of both stems conforms to the respective mylar overlays.Device history records (dhr) were reviewed and no discrepancies relevant to the reported event were found.Root cause could not be determined with information available.A summary of the investigation has been sent to the complainant.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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