Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Type
Injury
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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 - 2024 - 01029 0001822565 - 2024 - 01030 0001822565 - 2024 - 01031 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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Event Description
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It was reported that the patient has been experiencing allergy symptoms following a hip procedure.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.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.Medical records were not provided.A definitive root cause cannot be determined.Unable to confirm the complaint.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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