MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS TIBIAL PLATEAU CEMENTED T2+; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	NX054Z
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported to aesculap inc.That a vega knee implant system was implanted during a total knee arthroplasty surgical procedure performed on (b)(6) 2020.According to the complainant, following the procedure, the patient complained of knee pain.The complaint device was 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).
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
Involved components nx011z - as vega ps femoral comp.Cemented f5n l -52462656; nx220 - vega ps+ gliding surface t2/2+ 10mm - 52346119; nn261z - as tibial obturator d12mm - unknown; nx041 - patella 3-pegs p1 - 52536201.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T2+
• 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: 11344418
• Report Number: 2916714-2021-00012
• Device Sequence Number: 5036624
• Product Code: JWH
• UDI-Device Identifier: 04046963810436
• UDI-Public: 4046963810436
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021
• Report Date (Section F): 02/18/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: NX054Z
• Device Catalogue Number: NX054Z
• Device Lot Number: 52461032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/17/2020
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 12/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NN261Z - AS TIBIAL OBTURATOR D12MM - LOT UNKNOWN; NN261Z - AS TIBIAL OBTURATOR D12MM - LOT UNKNOWN; NX011Z - AS VEGA PS FEMORAL COMP - LOT 52462656; NX011Z - AS VEGA PS FEMORAL COMP - LOT 52462656; NX041 - PATELLA 3-PEGS P1 - LOT 52536201; NX041 - PATELLA 3-PEGS P1 - LOT 52536201; NX220 - VEGA PS+ GLIDING SURFACE - LOT 52346119; NX220 - VEGA PS+ GLIDING SURFACE - LOT 52346119
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 02/18/2021