Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Event Description
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It was reported that a screw broke and has caused loosening of the triflange shell.The patient has not been scheduled for a revision surgery to date.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 03537.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: g3; h2; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided for the screw.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.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 information is available at the time of this report.
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Search Alerts/Recalls
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