MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS TIBIAL PLATEAU CEMENTED T1; KNEE ENDOPROSTHETICS

Model Number NX051Z

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), 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 aag reference xc (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, 2916714-2020-00442, 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.

Event Description

No updates.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T1
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10535599
• MDR Text Key: 207225362
• Report Number: 2916714-2020-00441
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04046963810375
• UDI-Public: 4046963810375
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/15/2020,10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NX051Z
• Device Catalogue Number: NX051Z
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 09/15/2020
• Distributor Facility Aware Date: 09/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NN260P - PLUG F/TIBIAL PLATEAU; NX027Z - AS VEGA PS FEMORAL COMP.CEMENTED F3N R; NX042 - PATELLA 3-PEGS P2; NX100 - VEGA PS GLIDING SURFACE T0/0+ 10MM
• Patient Outcome(s): Required Intervention