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Model Number N/A |
Device Problems
Device Slipped (1584); Unintended Movement (3026)
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Patient Problem
No Code Available (3191)
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Event Date 07/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: foreign (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the patient has the product.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 knee arthroplasty and approximately three years after the procedure, it was prolonged for 2,5 cm.One month ago, it collapsed to the first position, failure of the expandable and patient was revised to a regular segmental rs femur system.It occurred in normal use.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Photographs and radiographs were provided, however the complaint cannot be confirmed.Visual examination of the provided pictures identified some light scratch marks on the device and it was not expanded.Review of the radiographs identified the following: there are no dates on the images provided and no dl stating the date taken.As there are no dates on image, and no images for comparison to assess the event reported, images being submitted for review to mmi would not enhance the investigation at this time.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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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