MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS FEMORAL COMP.CEMENTED F6R; KNEE ENDOPROSTHETICS

Model Number	NX034Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference code nx058z, device name as vega ps tibial plateau cemented t4+, serial number n/a, batch number 51924949, udi device identifier (b)(4), udi production identifier (b)(4), basic udi-di n/a, unit of use udi-di (b)(4), manufacturing date 2013-03-19.Reference code nx034z, device name as vega ps femoral comp.Cemented f6r, serial number n/a, batch number 52027658, udi device identifier (b)(4), udi production identifier (b)(4), basic udi-di n/a, unit of use udi-di (b)(4), manufacturing date 2014-04-23.Ref.Code device name batch: nn484, columbus patella 3-pegs p4 36x10mm, 52091050.Nx140, vega ps gliding surface t4/4+ 10mm, 52032726.Nn264z, as tibial obturator d14mm, 51958453.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 2 similar complaints against the same lot number 52091050 (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 or Problem Description
It was reported that there was an issue with a vega knee.It was reported that as a result of having the products implanted, the patient has experienced knee pain and instability.The patient claimed to have been able to hear "rattling" sounds postoperatively; results of x-rays showed loosening of the implant.The primary procedure occurred on (b)(6) 2015, and the revision was performed on (b)(6) 2018.Intraoperative findings were loosening of the tibial keel and femoral component.Surgical cement continued to adhere to the bone but had not adhered to the implant.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components: nn484 (columbus pri/rev pe patella 3-pegs p4), nx058z (ps tibia cemented t4+), nx140 (ps pe insert t4/t4+, 10mm), nn264z (tibial obturator d14mm, l7mm), nx034z (ps femur cemented f6 rt).The cement used was not specified.The adverse event / malfunction is filed under reference (b)(4).Associated medwatches: 2916714-2020-00583, 2916714-2020-00584, 2916714-2020-00585, 2916714-2020-00586.

• Brand Name: AS VEGA PS FEMORAL COMP.CEMENTED F6R
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10813576
• Report Number: 2916714-2020-00587
• Device Sequence Number: 4141941
• Product Code: HRY
• UDI-Device Identifier: 04046963810221
• UDI-Public: 4046963810221
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2020
• Report Date (Section F): 11/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: NX034Z
• Device Catalogue Number: NX034Z
• Device Lot Number: 52027658
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/18/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 11/09/2020