MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS TIBIAL PLATEAU CEMENTED T0; KNEE ENDOPROSTHETICS

Model Number NX049Z

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

Patient Problems Pain (1994); Synovitis (2094); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Reference code nx027z, device name as vega ps femoral comp.Cemented f3n r, serial number n/a, batch number 51821917, udi device identifier (b)(4), udi production identifier (b)(4), basic udi-di n/a, unit of use udi-di (b)(4), manufacturing date 2012-01-27.Ref.Code device name batch, nx042, patella 3-pegs p2, unknown.Nx049z, as vega ps tibial plateau cemented t0, 51770030.Nx102, vega ps gliding surface t0/0+ 14mm, unknown.Nn260p, plug f/tibial plateau, 51878787.Investigation: no product at hand.Therefore an investigation at the device is not possible.Pictorial documentation: there are no pictures available.Batch history review the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are 4 similar complaints against the same lot number: 51770030.(3 registered as leading component, 1 registered as involved component).There are 3 similar complaints against the same lot number: 51878787.(all registered as involved component,).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 (loosening) a product safety case (psc) was initiated.

Event Description

It was reported that there was an issue with as vega knee, right side.It was reported that as a result of having the products implanted, the patient has experienced knee pain and swelling; and normal daily activities were restricted due to the pain.The primary procedure occurred on (b)(6) 2012, and the revision was performed on (b)(6) 2018.Intraoperative findings were reactive synovitis with areas of necrotic tissue and loosening of the femoral component.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components: nx027z (ps femur cemented f3n rt), nx042 (universal patella p2), nx049z (ps tibia cemented t0), nx102 (ps pe insert t0/t0+, 14mm), nn260p (peek plug f/ tibia).The cement used was biomet cobalt hv bone cement.The adverse event / malfunction is filed under reference (b)(4).Associated medwatches: 2916714-2020-00605, 2916714-2020-00606, 2916714-2020-00608, 2916714-2020-00609.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T0
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10809201
• MDR Text Key: 217668825
• Report Number: 2916714-2020-00607
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04046963810337
• UDI-Public: 4046963810337
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Model Number: NX049Z
• Device Catalogue Number: NX049Z
• Device Lot Number: 51770030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2020
• Distributor Facility Aware Date: 02/15/2019
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention