Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Urinary Retention (2119)
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Event Date 06/09/2017 |
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.Concomitant medical products: item # us157850, cup, lot # 356200.Report source: interventions for improving hip resurfacing outcomes in women.Multiple reports have been submitted for this event.Please see associated report: 0001825034-2018-05187.
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Event Description
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It was reported in a journal article, a patient experienced complications approximately 3 years following hip resurfacing arthroplasty.Patients experienced urinary retention.Patient was treated and the case was resolved within 2 days.Additional surgery was not required.Attempts have been made, and no further information has been provided.
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Manufacturer Narrative
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This report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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 in a journal article, a patient experienced complications approximately 3 years following hip resurfacing arthroplasty.Patients experienced urinary retention.Patient was treated with catheterization, and the case was resolved within 2 days.Additional surgery was not required.Attempts have been made, and no further information has been provided.
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Search Alerts/Recalls
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