Model Number N/A |
Device Problems
Material Erosion (1214); Noise, Audible (3273)
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Patient Problems
Failure of Implant (1924); Necrosis (1971); Pain (1994); No Code Available (3191); Metal Related Pathology (4530)
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Event Date 10/12/2020 |
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 device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant medical products: 11-173664, femoral head, lot # 703940.11-162613, integral lat por 13x145mm, lot # 593320.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-11507.
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Event Description
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It was reported that approximately 16 years post implantation of the l hip, the patient has been experiencing pain, elevated metal ion levels, audible noise, and metal taste in mouth.Attempts have been made and no further information has been provided.
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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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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of lab reports which indicated results: chromium 11.6; cobalt: 32.3.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The additional information does not change the outcome of the previous investigation.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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It was reported that patient underwent a left hip revision approximately 20 years post implantation due to pain, elevated metal ion levels, noise, metal taste in mouth, metallosis, pseudotumor, metal tissue staining, and inflammatory tissue.Attempts have been made and no additional information is available at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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