MAUDE Adverse Event Report: AESCULAP AG AS COLUMBUS CR/PS TIB.PLAT.CEMENTED T4+; KNEE ENDOPROSTHESES

Model Number NN078Z

Device Problems Compatibility Problem (2960); Material Integrity Problem (2978)

Patient Problems Pain (1994); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 04/09/2018

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 a columbus tibia plateau.According to the complaint description as a result of having the product implanted the patient experienced knee pain, swelling, difficulty in walking and instability of the implant.Primary surgery: (b)(6) 2016.Revision surgery: (b)(6) 2017.A revision surgery was necessary.All available information has been provided at this time, if additional information becomes available the report will be updated accordingly.The adverse event is filed under aag reference (b)(4).

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 thel available lot number and were within specifications valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.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 COLUMBUS CR/PS TIB.PLAT.CEMENTED T4+
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10495064
• MDR Text Key: 205773456
• Report Number: 9610612-2020-00463
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K071220
• 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: 10/16/2020

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
• Device Operator: Health Professional
• Device Model Number: NN078Z
• Device Catalogue Number: NN078Z
• Device Lot Number: 52188592
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention