Model Number N/A |
Device Problems
Malposition of Device (2616); Migration (4003)
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Patient Problem
Unspecified Infection (1930)
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Event Date 08/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 32810502504, interchangeable humeral assembly for cemented use only small, 63694882.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565- 2018 - 04926.Product location unknown.
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Event Description
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It was reported that the patient underwent a right initial elbow arthroplasty and was revised due to loosening, malposition and possible infection with in one year post implantation.Attempts to obtain additional information have been made; however, no more 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.Reported event was confirmed by review of x-rays provided.X-ray determined lucency along the radial aspect of the humeral component at the cement hardware interface distally near the joint.No definite evidence for lucency along the ulnar component.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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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It was reported that the patient underwent a right initial elbow arthoplasty and was revised due to loosening, malposition and possible infection with in one year post implantation.Attempts to obtain additional information have been made; however, no more is available at this time.
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Search Alerts/Recalls
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