MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS TIBIAL PLATEAU CEMENTED T3+; KNEE ENDOPROSTHETICS

Model Number NX056Z

Device Problem Product Quality Problem (1506)

Patient Problems Patient Problem/Medical Problem (2688); Insufficient Information (4580)

Event Date 07/20/2020

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 ps tibial plateau.According to customer description, it was reported that the incident occurred on (b)(6) 2020.The implant is discolored on under side of baseplate and has two smudges on sides of baseplate; due do this fact, there was a surgery delay.There was no patient harm.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

The reporting decision is based upon the review of the applicable risk analysis.The review of the risk analysis after investigation revealed that the applicable failure mode is rated with a severity of 2(5).Based upon risk management review, we conclude that even if the reported failure is to reoccur, no serious injury for patient, user or third party is to be expected.The initial cfr reporting evaluation is no longer valid.Investigation results: visual investigation: investigation was carried out visually and microscopically.The surface of the implant which is intended for the bone cement shows a minimal greyish/silver discoloration.The mentioned "two smudges on side of baseplate" are position points for the as coating and no material or product failure.The grey/silver color is an oxidation effect which happens with all as coated if they are exposed to oxygen.It is an optical effect only and has no effect to the quality of the coating.This is also described in the instruction for use (ifu).There is no no material or product failure.No failure was detected during investigation.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 1(5)).Conclusion and measures / preventive measures: no failure of the device was detected during investigation.Based upon the investigations results a capa is not necessary.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T3+
• 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: 10425834
• MDR Text Key: 203524092
• Report Number: 9610612-2020-00365
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101281
• 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: 01/04/2022

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 Expiration Date: 02/01/2023
• Device Model Number: NX056Z
• Device Catalogue Number: NX056Z
• Device Lot Number: 51928246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 12/08/2021
• Supplement Dates FDA Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2013
• 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): Required Intervention