Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Sepsis (2067)
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Event Date 08/01/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a revision of the rotating hinged knee prosthesis in a septic context.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).G2: foreign - france.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02281, 0001822565-2023-02282, 0001822565-2023-02283.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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 underwent an initial right total knee arthroplasty on an unknown date.Subsequently, the patient was revised due to chronic infection.All components were revised without complications.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Part of the product was returned.However, testing was not done as visual examination is insufficient for the reported event of infection.The device history record was reviewed and no discrepancies relevant to the reported event were found.Additionally, the sterile certificate was reviewed and noted to be conforming.It was sterilized in accordance with fda regulations and iso standards.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: chronic right tka infection, multiple samples taken for bacteriological analysis, synovectomy extended with removal of two att screws, good range of motion.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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