MAUDE Adverse Event Report: AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F3R; KNEE ENDOPROSTHESES

Model Number NB019Z

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2020

Event Type  malfunction  

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 enduro femoral component.According to the complaint description it was reported that the femoral component had a tear in packaging so it could not be used due to sterility was void.There was no patient harm.Additional information was not provided nor available.The adverse event is filed under (b)(4).

Manufacturer Narrative

General information.We received a complaint about one nb019z -> as enduro femoral component cemented f3r from (b)(6) health service, (b)(6) australia.Up to now, there is neither the damaged packaging nor the device available for investigation.Consequences for the patient.Unknown.Information has been requested at the clinic at least three times.Investigation.No product at hand.Therefore an investigation at the device is not possible.The provided pictures show visible damages at the sterile package.This error was clearly visible and according ifu the implant may not be used any more.Batch history review.The device quality and manufacturing history records have been checked for the available lot number and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause.Based on the information available the root cause of the failure is most probably transport/usage related.Rationale.Due to the kind of damages we assume that the failure occurred most probably during the distribution and transport process to the hospital respectively in the hospital.Due to a 100% check it can be excluded that the product/packaging left the aag in such a condition.Corrective action: capa was created.

• Brand Name: AS ENDURO FEMORAL COMPONENT CEMENTED F3R
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9987225
• MDR Text Key: 188727534
• Report Number: 9610612-2020-00138
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K101815
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: NB019Z
• Device Catalogue Number: NB019Z
• Device Lot Number: 52427040
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1