MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS TIBIAL PLATEAU CEMENTED T2; PREVIOUSLY REPORTED

Model Number NX053Z

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544)

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.It was reported that as a result of having the product implanted, the patient has experienced left knee pain, a loss of mobility, and difficulty walking.The primary surgery occurred on (b)(6) 2013 and there was no reported revision surgery.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components: nx043 (universal patella p3).Nx011z (ps femur cemented f5n lt).Nn260p (peek plug f/ tibia).Nx121 (ps pe insert t2/t2+, 12mm).The cement used is unidentified.The adverse event / malfunction is filed under reference (b)(4).

Event Description

No updates.

Manufacturer Narrative

Investigation results: the affected device was not available for investigation.Therefore an investigation of the device was not possible.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.Associated medwatches: 2916714-2020-00206, 2916714-2020-00207, 2916714-2020-00208, 2916714-2020-00230, 2916714-2020-00231.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T2
• Type of Device: PREVIOUSLY REPORTED
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10231101
• MDR Text Key: 202691922
• Report Number: 2916714-2020-00231
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

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: NX053Z
• Device Catalogue Number: NX053Z
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NN260P - UNKNOWN; NX011Z - 51876883; NX043 - 51924244; NX121 - 51941007
• Patient Outcome(s): Required Intervention