MAUDE Adverse Event Report: AESCULAP AG ENDURO TIBIAL COMP.OFFSET CEMENTED T1 KNEE ENDOPROSTHESES

Model Number NB011K

Device Problems Delivered as Unsterile Product (1421); Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 nb011k, enduro tibial comp. Offset cemented t1. According to the complaint description, the implant expired. According to the packaging, the implant has been expired since may 2021. There was no described patient harm. The fault was detected before usage. Additional information was not provided. The malfunction is filed under aag reference (b)(4).

• Brand Name: ENDURO TIBIAL COMP.OFFSET CEMENTED T1
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12249423
• MDR Text Key: 264276718
• Report Number: 9610612-2021-00521
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/31/2021
• Device Model Number: NB011K
• Device Catalogue Number: NB011K
• Device Lot Number: 52249627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial