It was reported that there was an issue with the enduro knee system.Specifically, it was reported that as a result of having the product implanted the patient has experience, knee pain, difficulties in walking and swelling.The primary surgery occurred on (b)(6) 2017, and the revision surgery occurred on (b)(6) 2019.Additional information was not available.A revision was performed.The adverse event is filed under reference (b)(4).
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Manufacturing site evaluation: internal notification number: (b)(4).Device reference code ae-qas-k521-99, device name collect.No.Qas knee, impl.Misc./unknown, serial number n/a, batch number unknown, udi device identifier unknown, udi production identifier unknown, basic udi-di n/a, unit of use udi-di unknown, manufacturing date unknown.No product at hand.Therefore a failure description at the device is not possible.There are no pictures available.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Explanation and rationale: in the light of the little information received and due the circumstance that we did not received the complained devices it is not possible to determine a root cause for the mentioned failure.Conclusion and root cause: due to the current deviation and according the rationale, it is not possible to determine a root cause for the mentioned failure.Corrective action: this case concerning implant loosening (vega loosening) was assigned a product safety case (psc).
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