Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Burning Sensation (2146)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant devices - cement simplex tobr 6197-9-001, catalog #: n/a; lot#: mdt030.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Reference reports: 0001825034 - 2021 - 02093, 0001825034 - 2021 - 02097, 0001825034 - 2021 - 02098, 0001825034 - 2021 - 02099.
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Event Description
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It was reported patient underwent a right knee procedure approximately 8 years ago.Subsequently, the patient started feeling a burning sensation along with pain a few months ago.No revision procedure has been reported to date.Attempts have been made, but there is no additional information at this time.
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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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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.B3: event date: unknown month and day in 2020.
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Manufacturer Narrative
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The results of the investigation are as follows: -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.-a definitive root cause cannot be determined.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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