MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS FEMORAL COMP.CEMENTED F5N R; KNEE ENDOPROSTHESES

Model Number	NX031Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
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 that there was an issue with nx031z - as vega ps femoral comp.Cemented f5n r.According to the complaint description, the implants loosened post surgery.The patient experienced pain two years after the initial surgery.Early loosening was noted (x-rays taken due to symptoms prior to three years).A revision surgery was necessary.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00447 ((b)(4)+ nx055z).Involved components: nx130 - vega ps gliding surface t3/3+ 10mm - lot 52564765.
Additional Manufacturer Narrative
Investigation results: the femoral component arrived in an almost clean status with only slight bone cement adhesion.The tibial component arrived with bone cement residues adhesion.The investigation was carried out visually and microscopically.The available tibial component and femoral component show no abnormalities or serious visible damages.There are large scale bone cement residues on the tibial component in the current situation.Only slight bone cement residues can be found on the femoral component.The gliding component shows signs of usage of erratic appearance as well as slight damages.It could be possible that there were problems with the cement technique.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.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.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.
Event or Problem Description
Associated medwatch-reports: 9610612-2021-00447 (400515522 + nx055z).Involved components (aufführen in d11 + c2).Nx130 - vega ps gliding surface t3/3+ 10mm - lot 52564765.

• Brand Name: AS VEGA PS FEMORAL COMP.CEMENTED F5N R
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11959784
• Report Number: 9610612-2021-00448
• Device Sequence Number: 3741995
• Product Code: JWH
• UDI-Device Identifier: 04046963810160
• UDI-Public: 4046963810160
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K101281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: NX031Z
• Device Catalogue Number: NX031Z
• Device Lot Number: 52555687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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
• Patient Age: 70 YR