MAUDE Adverse Event Report: AESCULAP AG UNIVATION XF TIBIA ZEMENTIERT T4 LM; KNEE ENDOPROSTHETICS

Model Number NO165Z

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Implant Pain (4561)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

Investigation results: the affected device was not available for investigation.Therefore an investigation of the device was not possible.The device quality and manufacturing history records (dhr) were checked for all available lot numbers and were within specifications valid at the time of production.Two further incidents have been filed with nx049z lot 51770030 regarding implant loosening until today.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 Description

It was reported that there was an issue with no165z-as univation xf tibia zementiert t4 lm.It was reported on (b)(6) 2018, that as a result of having the product implanted, the patient has experienced unknown claims and it is known that it resulted in a revision surgery.The primary surgery occurred on (b)(6) 2016, and the revision surgery occurred on, (b)(6) 2017.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.The adverse event / malfunction is filed under aag reference (b)(4).Involved components: no188z (femur cemented f4 lm), nl473 (pe insert t4 rm/lm 7mm), nx044 (universal patella p4), np583r (threaded pin, headless 3.2mmx63mm).

• Brand Name: UNIVATION XF TIBIA ZEMENTIERT T4 LM
• Type of Device: KNEE ENDOPROSTHETICS
• 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: 11379836
• MDR Text Key: 242793454
• Report Number: 9610612-2020-00635
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NO165Z
• Device Catalogue Number: NO165Z
• Device Lot Number: 52231095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention