Model Number NP583R |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Internal notification number: 100025721 -> 400475708/ 400475709/ 400475710/ 400475711.Device, reference code no164z, device name as univation xf tibia cemented t3 lm, 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 nr.Manuf.Date no187z, as univation xf femur cemented f3lm unknown, unknown.Nl472, univation f meniscal comp.T3 rm/lm 7mm unknown, unknown.Np583r, threaded pin headless 3.2mm x 63mm unknown, unknown.Investigation: failure description: no product at hand.Therefore a failure description at the device is not possible.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.Conclusion and root cause: based on the information available it is not possible to determine a possible root cause for the mentioned failure.Corrective action: this case is concerning implant loosening.For this topic (univation 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 univation knee.It was reported that as a result of having the product implanted, the patient has experienced left knee pain, a loss of mobility, and difficulty walking.The primary surgery occurred on (b)(6) 2017, and there was no reported revision surgery.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components, no187z (as univation x femur cemented f3 lm), nl472 (univation x pe insert t3 rm/lm 7mm), np583r (threaded pin, headless 3.2mmx63mm), the cement used is unidentified.The adverse event / malfunction is filed under reference (b)(4).Associated medwatches: 2916714-2020-00232, 2916714-2020-00209, 2916714-2020-00210.
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Search Alerts/Recalls
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