Catalog Number 51-100130 |
Device Problems
Device Markings/Labelling Problem (2911); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 05/25/2021 |
Event Type
Injury
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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 the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the labeling on taperloc stem box did not specify that it was a standard fit instead of a reduced distal fit.Stem was implanted and patient experienced a femur fracture that was corrected with the use of cables.Attempts have been made and additional information on the reported event is unavailable at this time.
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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.The following sections were updated/corrected.Updated: g3; h2; h3; h6.Review of the products determined that no failure was found with the device as the products are within specifications.Review of the master labels for the standard fit and reduced distal fit found the products are labeled appropriately.As a result of a user error, the incorrect implant was implanted, which caused the patient's bone to fracture, which was resolved with cables.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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