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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pulmonary Embolism (1498); Chest Pain (1776); Death (1802)
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Event Date 01/27/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical product: persona femur cemented cruciate retaining (cr) catalog #: 42502605801, lot #: 64356382.Persona cr articular surface catalog #: 42511000410, lot #: 64457638.Persona all poly patella catalog # :42540000029, lot #: 64488661.The complainant has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 3007963827-2020-00048, 0002648920-2020-00086, 0002648920-2020-00087.Remains implanted.
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Event Description
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It was reported that the patient underwent a knee arthroplasty.During physical therapy, the patient experienced chest discomfort and collapsed.The patient required cpr, was transferred to an er and presumed to have a pulmonary embolism.The patient later expired after resuscitative efforts were unsuccessful.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Device was not returned.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.If a dvt/ blood clot breaks free, it may travel through the bloodstream and block blood flow to the lungs.This complication is called a pulmonary embolism.Total joint patients are typically placed on medication post-operative for a period of time to help prevent the development of dvt/blood clot formation that can lead to an pe.As the complaint indicated the patient may have developed a post-operative complication, it can be implied medical intervention was completed to treat the pe.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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