Model Number N/A |
Device Problems
Mechanical Problem (1384); Structural Problem (2506)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial report.The product has been requested to be returned to zimmer biomet for investigation.Medical product: unknown bearing component, catalog #: unknown, lot #: unknown.Medical product: unknown tibial component, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00045, 3002806535-2021-00047.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 a patient underwent an initial left knee arthroplasty on an (b)(6) 2017.Subsequently, a revision procedure due to instability was performed on (b)(6) 2021.
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Event Description
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It was reported that a patient underwent an initial left knee arthroplasty on an (b)(6) 2017.Subsequently, a revision procedure due to instability was performed on (b)(6) 2021.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00045-1, 3002806535-2021-00047-1.As the product has not been received, the investigation was limited to the information provided.We have not been provided with x-rays or any supporting documentation which could provide additional information.The item number and lot number identification necessary to review manufacturing history and the complaint history was not provided.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
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Search Alerts/Recalls
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