Model Number N/A |
Device Problems
Activation, Positioning or Separation Problem (2906); Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: foreign country: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0002648920 - 2020 - 00537.
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Event Description
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It was reported that during an initial surgery, the c-ring in bipolar shell was locked with shell and it would not assemble with polyethylene liner, which led to a 20 minute delay to change into new implant.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
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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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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.Visual review of the device as returned shows lock ring tab was not centered in the tab window.One tab was stuck in shell groove.Nicks, gouges, and deformation were noted to the lock ring.Lock ring was removed from the shell.Shell lock groove shows nicks and scratches.No other damage was noted to the shell.Lock ring was reinserted into the shell groove with tabs in shell tab window.The ring was able to move freely as intended within the lock ring groove.Review of the device history record for the shell identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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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