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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 08/03/2020 |
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 - 2020 - 03326, 0001825034 - 2020 - 03327, 0001825034 - 2020 - 03328.
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Event Description
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It was reported that the surgeon reamed and broached to the appropriate size for the implant being implanted.The surgeon indicated the implants did not fit the same way the broach fit.Each of the implants included in this were immediately explanted until the desired fit of the final implant was achieved.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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Cmp-0620794 this follow-up report is being submitted to relay additional information.Updated: b4, b5, g4, h2, h3, h6 complaint sample was evaluated and the reported event was not confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Device analysis indicated that the device met specification.Device was returned and evaluated against the complaint.Visual inspection found the stem to be in good overall condition with no major damage.Scratching was observed on the neck flats and polished distal tip of the stem.Dimensional analysis was performed to identify the stem.Both the overall length and porous thickness at cross section a-a were found to be within specification for a 9mm echo stem.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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