Model Number NX100 |
Device Problems
Mechanical Problem (1384); Loosening of Implant Not Related to Bone-Ingrowth (4002)
|
Patient Problems
Joint Laxity (4526); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/13/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Manufacturing evaluation: investigation on-going.Should additional relevant information become available, a supplemental medwatch report will be provided.
|
|
Event Description
|
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) (ref.Associated mdr id 2916714-2020-00439), 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), 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 aag reference (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.
|
|
Manufacturer Narrative
|
Associated medwatches: 2916714-2020-00439, 2916714-2020-00440, 2916714-2020-00441, 2916714-2020-00443.Reference code nx051z, device name as vega ps tibial plateau, cemented t1, batch number unknown, udi device identifier (b)(4).Udi production identifier unknown, 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.
|
|
Event Description
|
No updates.
|
|
Search Alerts/Recalls
|
|