It was reported to aesculap inc.That an as vega knee implant, comprised of the following components, as vega ps femoral comp.Cemented f3n r (part # nx027z), a patella 3-pegs p2 (part # nx042) (ref.Associated mdr id 2916714-2020-00440), a as vega ps tibial plateau cemented t1 (part # nx051z) (ref.Associated mdr id 2916714-2020-00441), a vega ps gliding surface t0/0+ 10mm (part # nx100) (ref.Associated mdr id 2916714-2020-00442), a plug f/tibial plateau (part # nn260p) (ref.Associated mdr id 2916714-2020-00443), was implanted on (b)(6) 2012.According to the complainant, the patient experienced loosening of the as vega knee, which resulted in a revision surgery being performed on (b)(6) 2019.The cement used during the primary surgery is unknown.No known adverse patient effects occurred as a result of the revision surgery.The complaint device is not available to be returned to the manufacturer for evaluation.Additional information has been requested, but has not been made available.The adverse event / malfunction is filed under (b)(4).Involved components: nx027z, as vega ps femoral comp.Cemented f3n r, lot # unknown.Nx042, patella 3-pegs p2, lot # unknown.Nx051z, as vega ps tibial plateau cemented t1, lot # unknown.Nx100, vega ps gliding surface t0/0+ 10mm, lot # unknown.Nn260p, plug f/tibial plateau, lot # unknown.
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Associated medwatches: 2916714-2020-00439, 2916714-2020-00440, 2916714-2020-00441, 2916714-2020-00442, 2916714-2020-00443.Reference code nx051z.Device name as vega ps tibial plateau cemented t1.Serial number n/a.Batch number unknown.Udi device identifier (b)(4).Udi production identifier unknown.Basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date unknown.Ref.Code device name batch.Nx027z as vega ps femoral comp.Cemented f3n r unknown.Nx042 patella 3-pegs p2 unknown.Nx100 vega ps gliding surface t0/0+ 10mm unknown.Nn260p plug f/tibial plateau unknown.Investigation: no product at hand.Therefore an investigation at the product is not possible.Pictorial documentation: 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.Corrective action: for this topic (vega loosening) a product safety case (psc) was initiated.
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