Model Number N/A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Products remain implanted, therefore they will not be returned for evaluation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.
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Event Description
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It was reported that the patient is suffering from terrible right knee pain after 10 years of initial surgery.
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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (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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It was reported that the patient is suffering from terrible right knee pain after 10 years of initial surgery.
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Manufacturer Narrative
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(b)(4).Udi: (b)(4).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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It was reported that the patient is suffering from terrible right knee pain after 10 years of initial surgery.
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Search Alerts/Recalls
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