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

Model Number NX051Z

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

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

Event Type  Injury  

Manufacturer Narrative

Reference code (b)(4).Device name as vega ps femoral comp.Cemented f5n l.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.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: (b)(4).Manufacturing date unknown.Ref.Code device name batch.Nx042 patella 3-pegs p2 unknown.Nx112 vega ps gliding surface t1/1+ 14mm unknown.Nn260p plug f/tibial plateau unknown.Investigation: no product at hand.Therefore an investigation at the device is not possible.Pictorial documentation: there are no pictures available.Batch history review: due to the fact that no lot numbers were 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 (loosening) a product safety case (psc) was initiated.

Event Description

It was reported that there was an issue with as vega knee, left side.It was reported that as a result of having the products implanted, the patient has experienced bilateral knee pain and swelling; and normal daily activities were restricted due to the pain.The primary procedure occurred on (b)(6) 2013, and the revision was performed on (b)(6) 2018.Intraoperative findings showed loosening of the femoral and tibial components.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components: nx011z (ps femur cemented f5n lt), nx042 (universal patella p2), nx051z (ps tibia cemented t1), nx112 (ps pe insert t1/t1+, 14mm), nn260p (peek plug f/ tibia).The cement used was palacos r radiopaque bone cement.The adverse event / malfunction is filed under reference xc (b)(4).Associated medwatches: 2916714-2020-00545, 2916714-2020-00546, 2916714-2020-00548, 2916714-2020-00549.The same patient has an adverse event / malfunction filed under reference xc (b)(4) (right knee).

• 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: 10803362
• MDR Text Key: 217090414
• Report Number: 2916714-2020-00547
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04046963810375
• UDI-Public: 4046963810375
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2020
• 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