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

Model Number	NX011Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Implant Pain (4561); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: the affected device was not available for investigation.Therefore an investigation of the device was not possible.Due to the lack of information the device quality and manufacturing history records (dhr) can not be checked.The determination of a definite root cause is due to the non-availability of important information and the device itself not possible.The conclusion from the root cause analysis is that a systematic device deviation is unlikely since the received complaints are limited to certain health care institutions and their applicants.The participation of the applicants in this deviation scenario cannot be excluded by today.Based on the root cause analysis result no corrective actions have been carried out.As a preventive action we were in contact with the affected health care institutions and applicants in order to reduce the probability of recurrence.The complaints were submitted to aesculap ag as a summary report.In order to examine further actions, all cases from the summary report are processed as vigilance suspicion cases and are continuously monitored.
Event or Problem Description
It was reported that there was an issue with nx011z-as vega ps femoral comp.Cemented f5n l.It was reported on (b)(6) 2019 that as a result of having the product implanted, the patient has experienced pain and swelling in both knees, and normal daily activities were restricted due to this pain.Intraoperative findings during replacement surgeries were loosening of the tibial and femoral components which resulted in a revision surgery.The primary surgery occurred on (b)(6) 2013, and the revision surgery occurred on (b)(6) 2018.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Cement used: palacos r radiopaque bone cement.Involved components: nx042 (universal patella p2), nx112 (ps pe insert t1/t1+, 14mm), nn260p (peek plug f/ tibia).The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch report: 9610612-2020-00559 (nx051z 400485940).The same patient has an adverse event / malfunction filed under reference xc (b)(4) ( right knee).

• Brand Name: AS VEGA PS FEMORAL COMP.CEMENTED F5N L
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11165849
• Report Number: 9610612-2020-00558
• Device Sequence Number: 11691930
• Product Code: JWH
• UDI-Device Identifier: 04046963809904
• UDI-Public: 4046963809904
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• 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
• Report Date (Section B): 01/13/2021

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: NX011Z
• Device Catalogue Number: NX011Z
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 01/13/2021
• 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