MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS TIBIAL PLATEAU CEMENTED T3+; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	NX056Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Implant Pain (4561); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for all available lot numbers; the devices were found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
It was reported to aesculap inc.That an vega knee implant system, comprised of the following components, vega system tibia obturator (part # nn264z) (ref.Associated mdr id 2916714-2020-00589), columbus patella size p4 (part # nn484) (ref.Associated mdr id 2916714-2020-00590), vega system ps femur f6n r (part #nx033z) (ref.Associated mdr id 2916714-2020-00591), vega system ps tibia plateau t3+, cemented implant (part # nx056z), and a vega system ps gliding surface implant 12mm t3/t3+ (part # nx131) (ref.Associated mdr id 2916714-2020-00593), was implanted during a primary surgery performed on (b)(6) 2016.According to the complainant, following the primary surgery, the patient experienced knee pain (mostly located on the inside of the knee joint), weakness in right knee, and difficulty with climbing stairs and rising from a seated position.A subsequent x-ray showed loosening of the tibial implant, which resulted in a revision surgery performed on (b)(6)2017.Post-replacement surgery findings showed loosening of the tibial and femoral components.The cement used during the primary surgery is unknown.No known adverse patient effects occurred as a result of the revision surgery.The complaint device is not available to be returned to the manufacturer for evaluation.Additional information has been requested, but has not been made available.The adverse event / malfunction is filed under aag reference (b)(4).Involved components: nn264z - as tibial obturator d14mm - lot # 52182218, nn484 - columbus patella 3-pegs p4 36x10mm - lot # 52158619, nx033z - as vega ps femoral comp.Cemented f6n r - lot # 52133992, nx056z - as vega ps tibial plateau cemented t3+ - lot # 52138447, nx131 - vega ps gliding surface t3/3+ 12mm - lot # 52137435.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T3+
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10823648
• Report Number: 2916714-2020-00592
• Device Sequence Number: 11655023
• Product Code: JWH
• UDI-Device Identifier: 04046963810450
• UDI-Public: 4046963810450
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2020
• Report Date (Section F): 11/11/2020

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: 04/30/2025
• Device Model Number: NX056Z
• Device Catalogue Number: NX056Z
• Device Lot Number: 52138447
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/18/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/18/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2020
• 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: 11/11/2020