Model Number AE-QAS-K521-99 |
Device Problems
Unstable (1667); Patient-Device Incompatibility (2682)
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Patient Problems
Edema (1820); Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Weight Changes (2607)
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Event Type
Injury
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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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Event Description
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It was reported that there was an issue with as enduro femoral component.The patient was initially implanted with enduro components on (b)(6) 2019.It was noted that the patient experienced instability of knee joint, knee pain, infection-inflammation, lymphedema, nickel allergy, and sudden unexplained weight loss.There later was a failed total knee and revision on (b)(6) 2020.A revision surgery was necessary.The implant that was revised was the aesculap enduro femur.Additional information was requested.Operative records were not provided.The adverse event is filed under xc (b)(4).
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Manufacturer Narrative
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Section d: leading material updated.
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Event Description
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No update provided.
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Manufacturer Narrative
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General information: we received a complaint regarding enduro components.This is one of 12 cases regarding "problems with enduro components." up to now, there are no devices available for investigation.Consequences for the patient: post-operative medical intervention was necessary.Revision surgery.Investigation: no product at hand, therefore an investigation at the devices is not possible.Batch history review: a review of the device quality and manufacturing history records is not possible because the material number as well as the batch number is unknown.Conclusion and root cause: based on the information available it is not possible to determine a definitive root cause for the failure at that time.Rationale: on the basis of the current information and without a product for investigation, a clear conclusion/root cause for the implant loosening can not be drawn.Corrective action: product safety case was created.
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Event Description
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No update provided.
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Search Alerts/Recalls
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