Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Anemia (1706); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a right hip arthroplasty.Subsequently, patient is allegedly experiencing pain, difficulty walking, losing blood and is severely anemic.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 02179, 0001822565 - 2023 - 02181, 0001822565 - 2023 - 02182.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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No further information at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined for the pain and difficulty ambulating.No problem was found with the devices in relation to the blood loss and anemia after review by a hcp.This complaint cannot be confirmed.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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Search Alerts/Recalls
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