Model Number N/A |
Device Problems
Off-Label Use (1494); Detachment of Device or Device Component (2907)
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Patient Problem
Failure of Implant (1924)
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Event Date 05/31/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: microport cat#pha04444 delta option head lot#1765758, microport cat#pha044md delta option neck sleve lot#1804123, microport cat#pprcls05 profemur preserve classic stem lot#1801102.Foreign source: canada.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the patient underwent hip surgery.Subsequently, patient was revised approximately 1 (one) year later due to the acetabulum separating (ceramic from metal).Attempts have been made and additional information on the reported event is unavailable 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 updated: h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.Therefore, a definitive root cause cannot 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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No further event information available at the time of this report.
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Search Alerts/Recalls
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