Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Host-Tissue Reaction (1297); Edema (1820)
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Event Date 07/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation is completed, a follow up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03903.
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Event Description
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It was reported that patient underwent a revision surgery approximately 12 years post implantation due to suspicion of pseudotumor and occurrence of edema.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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Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 additional event information to report at this time.
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Search Alerts/Recalls
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