MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS FEMORAL COMP.CEMENTED F3N R; KNEE ENDOPROSTHETICS

Model Number NX027Z

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems No Code Available (3191); Joint Laxity (4526)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

If follow-up information or manufacturing investigation is provided, a supplement will be submitted.

Event Description

It was reported that there was an issue with as vega knee.It was reported that as a result of having the product implanted, the patient has experienced loosening which resulted in a revision surgery.The primary procedure occurred on (b)(6) 2012, and the revision was performed on (b)(6) 2020.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components: as vega system ps, as patella p2, as vega ps tibial plateau cemented, as vega ps gliding surface t0/t0 10mm, as vega peek plug t1 - t5.The cement used is unidentified.The adverse event / malfunction is filed under reference (b)(4).Associated medwatches: 2916714-2020-00445, 2916714-2020-00446, 2916714-2020-00447, 2916714-2020-00448.

Manufacturer Narrative

Associated medwatches: 2916714-2020-00444, 2916714-2020-00445, 2916714-2020-00446, 2916714-2020-00447, and 2916714-2020-00448.Reference code 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 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.

Manufacturer Narrative

Associated medwatches: 2916714-2020-00444, 2916714-2020-00445, 2916714-2020-00446, 2916714-2020-00447, 2916714-2020-00448.Correction: awareness date for follow-up #1 mdr was (b)(6) 2020.

Event Description

No updates.

• Brand Name: AS VEGA PS FEMORAL COMP.CEMENTED F3N R
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10495269
• MDR Text Key: 206353120
• Report Number: 2916714-2020-00444
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NX027Z
• Device Catalogue Number: NX027Z
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/06/2020
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention