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Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problems
Pain (1994); Swelling (2091); Burning Sensation (2146)
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Event Date 07/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Associated products : item#: 00588605412; ps monoblock tibial component: sz4 c-d,12mm; lot#: 62970214; item#:00587806532; nexgenâ® complete knee solution, standard primary patella; lot#: 64227884.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is 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: 3005751028-2021-00005, 3005751028-2021-00006.
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Event Description
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It was reported the patient underwent a right tka approximately 1.5 years ago.Subsequently, it was noted the patient is dissatisfied with the outcome of the knee as well as experiencing moderate to severe pain.Pain medications were prescribed and noted as tolerated.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record (dhr) review found no anomalies/discrepancies related to the reported event.Review of office notes states burning sensation over lateral knee mostly at night, pain rates at 6, swelling of bilateral feet and right calf pain and pain when compressed, worse with activity.Additionally, patient feels like knee gives out with prolonged walking or standing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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