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Model Number N/A |
Device Problems
Material Erosion (1214); Mechanical Jam (2983)
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Patient Problem
Metal Related Pathology (4530)
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Event Date 06/21/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent an initial hip arthroplasty on an unknown day.Subsequently, the patient was revised due to metallosis.During the revision, the stem was cold welded with the head and had to be revised.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown magnum cup, unknown head, unknown stem.Multiple reports were submitted along with this report 0001825034-2022-01630, 0001825034-2022-01631, 0001825034-2022-01632.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h1, h2, h3, h6, h10 h6: proposed component code: mechanical (g04)- head reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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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