MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS TIBIAL PLATEAU CEMENTED T1; KNEE ENDOPROSTHETICS

Model Number NX051Z

Device Problems Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Joint Disorder (2373); Implant Pain (4561)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with as vega tibial plateau.As a result of having the product implanted, the patient has experienced loosening of as vega knee implant which resulted in a revision surgery.The primary surgery occurred on (b)(6) 2013, and the revision surgery occurred on (b)(6) 2019.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components: as vega ps femoral comp.Cemented f4n l nx009z- unknown.Patella 3-pegs p2 nx042-unknown.Vega ps gliding surface t1/1+ 12mm-unknown.Vega ps gliding surface t1/1+ 12mm-unknown.Plug f/tibial plateau-unknown.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Involved components: as vega ps femoral comp.Cemented f4n l nx009z- unknown; patella 3-pegs p2 nx042-unknown; vega ps gliding surface t1/1+ 12mm-unknown; vega ps gliding surface t1/1+ 12mm-unknown; plug f/tibial plateau-unknown.Investigation results: the affected device was not available for investigation.Therefore an investigation of the device was not possible.Due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.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.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T1
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10516407
• MDR Text Key: 206504613
• Report Number: 9610612-2020-00484
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K101281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NX051Z
• Device Catalogue Number: NX051Z
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NN260P-UNKNOWN; NX009Z-UNKNOWN; NX042-UNKNOWN; NX111-UNKNOWN
• Patient Outcome(s): Required Intervention