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Model Number N/A |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 10/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation, however it has not been received.If the device is returned, a new investigation will be conducted and a follow-up mdr will be submitted.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported that the patient underwent shoulder replacement surgery.During the procedure the surgeon asked for a 18x55 stem.After verifying on the box the correct size, the stem was handed to the circulator to open onto the sterile field.As the surgeon was handed the implant, he noticed that it was way too big compared to what we normally implant.Package was checked and confirmed everything said it was supposed to be a 18x55 micro stem but instead the implant was a 19x122 stem.Knowing another set of micro stems were not available, the surgeon elected to use a mini stem which resulted in a fracture of the humorous.Attempts have been made and no further information has been provided.
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Search Alerts/Recalls
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