Model Number N/A |
Device Problem
Biocompatibility (2886)
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Patient Problems
Inflammation (1932); Metal Related Pathology (4530)
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Event Date 01/09/2024 |
Event Type
Injury
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Event Description
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It was reported that patient underwent revision post implantation due to metal ion reaction with pseudotumor formation and liquid collection of inflammatory material.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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(b)(4): g2: report source italy.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will besubmitted.Multiple mdr reports were filed for this event, please see associated reports: (b)(4).
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Manufacturer Narrative
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(b)(4): this follow-up report is being submitted to relay additional information.The product was not returned; therefore, visual and dimensional evaluations could not be performed.A review of the complaint history for the unknown cup could not be performed due to missing reference and lot numbers.With the available information, a definitive root cause could not 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 further event information available at the time of this report.
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Search Alerts/Recalls
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