MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS TIBIAL PLATEAU CEMENTED T2+; KNEE ENDOPROSTHESES

Model Number	NX054Z
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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, the implant failed to properly react with the palacos mv with antibiotic cement used for fixation.The patient will undergo a revision surgery of the right knee.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).
Event or Problem Description
No updates.
Additional Manufacturer Narrative
Investigation results as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T2+
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11345115
• Report Number: 2916714-2021-00011
• Device Sequence Number: 5036626
• 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): 12/15/2021
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NX054Z
• Device Catalogue Number: NX054Z
• Device Lot Number: 52375217
• 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: 38 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2020
• Type of Report(Section G): Follow-Up
• 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: 12/16/2021
• 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: NX031Z - AS VEGA PS FEMORAL COMP - LOT 52526922
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 02/18/2021