Model Number N/A |
Device Problem
Separation Failure (2547)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/17/2017 |
Event Type
Injury
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Manufacturer Narrative
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The complaint number corresponding to this medwatch is (b)(4).It is unknown if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Concomitant product(s):- a 110003450 g7 str monoblock shell insrtr 014970.A 110010245 g7 osseoti 4 hole shell 54mm f 3965695.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-04172 & 0001825034-2017-04174.
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Event Description
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It was reported that the surgeon was unable to turn the handle with out moving the cup.The impactor became lodged with the cup causing the cup to be removed and replaced.The procedure was completed with a different.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination confirms that the inserter was locked to the shell apex hole.Moderate pressure was applied to the inserter and was unsuccessful in disengaging it from the cup, therefore no further analysis is performed at this time.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause for the reported event could not be determined with the information available.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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Manufacturer Narrative
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This follow-up report is being filled to relay a additional information.
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Search Alerts/Recalls
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