Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Event date was sometime in (b)(6) 2018.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to device location unknown.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 - 2018 - 09984.
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Event Description
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It was reported that during hip surgery, the 2 modular components would not seat fully using a standard torque wrench.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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Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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