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 02/28/2021 |
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.Unique identifier (udi) #: n/a.Concomitant medical products: rd118852, cup, lot # 636580; x11-180313, bi-metric/x por nc lat 13x145, lot # 25362.0 multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-11511.
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Event Description
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It was reported that approximately 16 years post implantation of the r 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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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of laboratory records.Dhr was reviewed and no discrepancies relevant to the reported event 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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Event Description
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It was reported that patient underwent a right hip revision approximately 18 years post implantation due to pain, elevated metal ion levels, noise, metal taste in mouth, necrosis and inflammatory tissue causing excessive metal wear of the magnum implant.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.The following sections were updated/corrected h6: component code: mechanical (g04) ¿ head 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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Search Alerts/Recalls
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