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

Model Number	NX049Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference code: nx009z.Device name: as vega ps femoral comp.Cemented f4n.Serial number: n/a.Batch number: 51963203.Udi device identifier (b)(4).Udi production identifier: (b)(4).Basic udi-di: n/a.Unit of use udi-di (b)(4).Manufacturing date: 203-09-09.Reference code: nx049z.Device name: as vega ps tibial plateau cemented t0.Serial number: n/a.Batch number: 51938559.Udi device identifier (b)(4).Udi production identifier: (b)(4).Basic udi-di: n/a.Unit of use udi-di (b)(4).Manufacturing date: 2013-03-30.Ref.Code device name: batch.Nx042 patella 3-pegs p2 51954906.Nx103 vega ps gliding surface t0/0+ 16mm 51912366.Nn260p plug f/tibial plateau 51959433.Investigation: no product at hand.Therefore an investigation at the product 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 5 similar complaints against the same lot number: 51963203.(3 registered as leading component; 2 registered as involved components).There are 3 similar complaints against the same lot number: 51938559.(all registered as leading component).There are 3 similar complaints against the same lot number: 51954906.(all registered as involved component).There are 2 similar complaints against the same lot number: 51959433.(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 (vega loosening) a product safety case (psc) was initiated.
Event or Problem Description
It was reported that there was an issue with vega knee components.As a result of having the product implanted the patient has experienced pain and swelling in left knee and normal daily activities was restricted due to pain.Intraoperative findings during replacement surgery were a well-fixed patellar component and loosening of the tibial and femoral components, which resulted in revision surgery.The primary surgery occurred on (b)(6) 2013 and the revision surgery occured on (b)(6) 2016.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 (b)(4).Involved components: nx009z (ps femur cemented f4n lt).Nx042 (universal patella p2).Nx049z (ps tibia cemented t0).Nx103(ps pe insert t0/t0+,16mm).Nn260p (peek plug f/tibia).Associated medwatches: 2916714-2020-00500, 2916714-2020-00501, 2916714-2020-00503, 2916714-2020-00504.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T0
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10804615
• Report Number: 2916714-2020-00502
• Device Sequence Number: 11685972
• Product Code: JWH
• UDI-Device Identifier: 04046963810337
• UDI-Public: 4046963810337
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2020

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: 03/01/2023
• Device Model Number: NX049Z
• Device Catalogue Number: NX049Z
• Device Lot Number: 51938559
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/15/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2020
• 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