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
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 nx012z - as vega ps femoral comp.Cemented f5l.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 aag reference (b)(4).Involved components: nx056z - as vega ps tibial plateau cemented t3+ - 52001076, nx063z - as tibia extension stem 14x52mm cemented - 52066679.
Event or Problem Description
Involved components nx056z - as vega ps tibial plateau cemented t3+ - 52001076 nx063z - as tibia extension stem 14x52mm cemented - 52066679 update.The loosening was noted via x-ray results dated 17feb2021; the revision occurred on 13apr2021.
Additional Manufacturer Narrative
Updated: patient information in a, b5 event description, d6 revision date investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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.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.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 FEMORAL COMP.CEMENTED F5L
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11745115
• Report Number: 9610612-2021-00370
• Device Sequence Number: 3984728
• Product Code: JWH
• UDI-Device Identifier: 04046963809928
• UDI-Public: 4046963809928
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K101281
• 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: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 09/03/2021
• 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; NX056Z - 52001076; NX063Z- 52066679; NX063Z- 52066679
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR