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Model Number N/A |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Unspecified Infection (1930)
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Event Date 02/14/2020 |
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 discarded by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: unknown femoral stem.Unknown liner.Unknown shell.Unknown augment.Report source: event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00685 0001822565-2020-00687.
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Event Description
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It was reported that in an unknown timeframe post implantation, the patient was revised of the hip components due to infection.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.The reported event was unable to be confirmed due to limited information received from the reporter.No devices, photos, or operatives notes were provided.X-rays were received and were of poor quality.Furthermore, evaluation of the x-rays would not enhance the investigation as the event is for infection.A review of the device history records was unable to be performed as the part and lot numbers were not provided.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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