MAUDE Adverse Event Report: AESCULAP AG PATELLA 3-PEGS P2; KNEE ENDOPROSTHETICS

Model Number NX042

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

Patient Problems No Known Impact Or Consequence To Patient (2692); Joint Laxity (4526)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with a vega knee components.It was reported that as a result of having the product implanted, the patient has experienced as vega knee loosing which results in a revision surgery.The primary surgery occurred on (b)(6) 2013 and revision surgery occurred on (b)(6) 2019.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 xc (b)(4).Involved components: nx029z (as vega ps femoral comp.Cemented f4n r), nx042 (patella 3-pegs p2), nx051z (as vega ps tibial plateau cemented t1), nx112(vega ps gliding surface t1/1+ 14mm), nn260p (plug f/tibial plateau).Associated medwatches: 2916714-2020-00452, 2916714-2020-00454, 2916714-2020-00455, and 2916714-2020-00456.

Manufacturer Narrative

The adverse event / malfunction is filed under reference (b)(4).Associated medwatches: 2916714-2020-00452, 2916714-2020-00453, 2916714-2020-00454, 2916714-2020-00455, 2916714-2020-00456.Reference code (b)(4).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.Nx029z as vega ps femoral comp.Cemented f4n r unknown.Nx042 patella 3-pegs p2 unknown.Nx112 vega ps gliding surface t1/1+ 14mm unknown.Nn260p tibia-verschlussstopfen 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.

• Brand Name: PATELLA 3-PEGS P2
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10490642
• MDR Text Key: 205884469
• Report Number: 2916714-2020-00453
• 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
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NX042
• Device Catalogue Number: NX042
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/21/2020
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention