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Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Joint Swelling (2356)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant products: unknown zimmer femoral, item # unknown, lot # unknown.Unknown zimmer bearing, item # unknown, lot # unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation due to the device still implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-04017 and 0001822565-2017-04019.
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Event Description
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It was reported following a knee arthroplasty, the patient is experiencing pain and extreme swelling.The patient has been using ice to provide relief on the pain and swelling.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
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Manufacturer Narrative
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(b)(4).The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The compatibility check and complaint history search were not performed.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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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