Model Number N/A |
Device Problem
Migration (4003)
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Patient Problem
No Information (3190)
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Event Date 10/18/2018 |
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 was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Event occurred in (b)(6).
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Event Description
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It was reported that approximately six (6) years post implantation, the patient underwent elbow arthroplasty revision due to loosening of the humeral component.Attempts have been made and no further information has been provided.
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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 radiographs and pictures.X-ray review demonstrated right elbow hinged prosthesis with suggestion of significant osteolysis involving the bone cement interface of the humeral component with possible loosening more distally.The ulnar component appears to be well-seated.Device history record (dhr) was reviewed and no discrepancies were found.A definite root cause cannot be determined with the information 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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