Catalog Number 110003453 |
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 Date 03/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as product location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted concomitant medical products: item # 110010246/ g7 osseoti 4 hole shell/ lot # 6639380.
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Event Description
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It was reported that during the hip surgery, the surgeon had to continually tighten the cup as it continued to come loose when impacted with mallet.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 following sections were updated/corrected updated: g4; h2; h3; h5; h6.Reportable event was unable to be confirmed due to limited information received from customer.Device history record (dhr) review was unable to performed as the lot number of the devise involved in the event is unknown, root cause was unable to 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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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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