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 n/a, udi production identifier unknown, basic udi-di n/a, unit of use udi-di n/a, manufacturing date unknown.Investigation: no product at hand.Therefore an investigation at the device is not possible.Pictorial documentation: there are no pictures available.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.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 an exact conclusion and root cause.Corrective action: for this topic a product safety case (psc) was initiated.
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It was reported that there was an issue with as vega knee, left side.The patient had experienced pain and instability the knee.X-rays showed loosening of the implant.The primary implantation was performed on (b)(6) 2016, and the revision surgery occurred on (b)(6) 2019.A revisions was necessary.All available information has been provided at this time; if additional information becomes available the complaint will be updated accordingly.The adverse event / malfunction is filed under reference (b)(4).
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