Model Number N/A |
Device Problem
Failure to Osseointegrate (1863)
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Patient Problems
Fall (1848); Failure of Implant (1924)
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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 the 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 patient is undergoing plans for a left hip revision after an unknown amount of time post implantation due to pelvic discontinuity causing the shell to fail to fixate and no in growth as expected with condition.The patient has noted that they have stumbled a few times since the initial procedure.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: g3; h2; h6.Medical records were not provided.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be 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 additional event information to report at this time.
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Search Alerts/Recalls
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