Model Number AE-QAS-K521-55 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Implant Pain (4561)
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Event Date 05/03/2021 |
Event Type
Injury
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Event Description
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It was reported that there was an issue with aesculap010 - aesculap surgical instruments.According to the complaint description, the as enduro knee (right knee) was revised due to pain, swelling and loosening.The as endoro was allegedly implanted on (b)(6) 2019 and revised on (b)(6) 2021.A revision surgery was necessary.Additional information was not provided.Additional patient information is not available.(b)(4).
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Manufacturer Narrative
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Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that neither an article number nor a lot number was provided, a review of the device history records must remain incomplete.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material, manufacturing or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.
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Event Description
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Article code was changed from unknown (aesculap010) to a collection number of knee implants - ae-qas-k521-55.But the specific item code is still unknown (as enduro).
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Search Alerts/Recalls
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