MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS FEMORAL COMP.CEMENTED F5L; KNEE ENDOPROSTHESES

Model Number	NX012Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results become available, they will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with a as vega ps femoral component.According to the complaint description, a vega femur was revised and it was noted "no cement was found on backside of implant".Loosening was also noted.The initial surgery was (b)(6) 2017.A revision surgery was necessary.Additional information was not provided nor available / was not available.The adverse event is filed under xc reference (b)(4).Involved components: nx056z - as vega ps tibial plateau cemented t3+ - 52001076.Nx063z - as tibia extension stem 14x52mm cemented - 52066679.
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 have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Explanation and rationale: in the light of the small amount of information received and due to the circumstance that we did not receive the complained devices for investigation, it is not possible to determine a definitive root cause for the mentioned failure.It could be possible that there were problems with the cement technique and due to this the implant has loosened prematurely.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.A capa is not necessary.
Event or Problem Description
Update: the loosening was noted via x-ray results dated (b)(6) 2021; the revision occurred on (b)(6) 2021.

• Brand Name: AS VEGA PS FEMORAL COMP.CEMENTED F5L
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11745266
• Report Number: 2916714-2021-00070
• Device Sequence Number: 4225987
• Product Code: JWH
• UDI-Device Identifier: 04046963809928
• UDI-Public: 4046963809928
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021
• Report Date (Section F): 04/29/2021

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 Expiration Date: 06/30/2026
• Device Model Number: NX012Z
• Device Catalogue Number: NX012Z
• Device Lot Number: 52250138
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/01/2021
• Device Age: 55 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 09/07/2021
• 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: NX056Z - 52001076.; NX063Z- 52066679.; NX056Z - 52001076; NX063Z- 52066679
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Date Report Sent to FDA: 04/29/2021