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

Model Number NX051Z

Device Problems Patient-Device Incompatibility (2682); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

If additional information or evaluation results become available, a supplemental report will be submitted.

Event Description

It was reported that there was an issue with as vega ps tibial plateau.It was reported that as a result of having the product implanted, the patient has experienced loosening of the knee implant which resulted in a revision surgery.The primary surgery occurred on (b)(6) 2013 and the 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.Involved components: as vega system ps, as patella p2, as vega ps tibial plateau cemented, as vega ps gliding surface, as vega peek plug.Cement used is unidentified.At the time of entry, there was only one product code mentioned the other components are unknown and complaint will be updated when more information is received.The adverse event / malfunction is filed under xc reference (b)(4).

Manufacturer Narrative

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.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: 10507852
• MDR Text Key: 206175175
• Report Number: 2916714-2020-00433
• Device Sequence Number: 1
• Product Code: JWH
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Distributor Facility Aware Date: 09/30/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention