Model Number NX100 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Ambulation Difficulties (2544); Joint Laxity (4526)
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Event Type
Injury
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Manufacturer Narrative
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Nx049z.Device name as vega ps tibial plateau.Cemented t0.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: nx009z, device name: as vega ps femoral comp.Cemented f4n l, batch: 52137600; nx100, vega ps gliding surface t0/0+ 10mm, 51947691; nn260p, plug f/tibial plateau, 52119154; nx042, patella 3-pegs p2, 52120719.Investigation: no product at hand.Therefore an investigation at the product is not possible.Pictorial documentation there are no pictures available.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are 3 similar complaints against the same lot number 52137600.(2 as involved components).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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Event Description
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It was reported that there was an issue with as vega knee.As a result of having the product implanted the patient has experienced knee pain, swelling, difficulty walking, and loosening and instability of the implant.The primary surgery occurred on (b)(6) 2015 and the revision surgery occurred on (b)(6) 2016.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).Associated medwatches: 2916714-2020-00411, 2916714-2020-00413, 2916714-2020-00414, 2916714-2020-00415.Involved components: nx009z (ps femur cemented f4n lt).Nx100 (ps pe insert t0/t0+, 10mm).Nx049z (ps tibia cemented t0).Nn260p (peek plug f/ tibia).Nx042 (universal patella p2).The cement used is unidentified.
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Search Alerts/Recalls
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