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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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: 0001822565-2023-02280, 0001822565-2023-02282, 0001822565-2023-02283.
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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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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.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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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.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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Search Alerts/Recalls
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