Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Code Available (3191)
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Event Date 11/06/2018 |
Event Type
Injury
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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 has been reported that during comprehensive shoulder arthroplasty, the 11mm mini humeral stem sat 4mm proud, after broaching.Surgery was completed using a 10mm mini stem.No additional patient consequences were reported.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Complaint sample was evaluated and the reported event was not confirmed.Product was returned for evaluation and as per visual inspection showed any no visible damage.Dimensions taken are within specifications.Dhr was reviewed and no discrepancies were found.Device analysis indicated that the device met specification.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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