MAUDE Adverse Event Report: AESCULAP AG ORTHOPILOT BASIS COMPACT ORTHOPILOT NAVIGATION SYSTEM

Model Number FS101

Device Problem Compatibility Problem (2960)

Patient Problem Unspecified Infection (1930)

Event Date 11/26/2019

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 orthopilot basis. Following customer information was reported: study: (b)(6). The implantation was on (b)(6) 2019. Postoperative (po) suspicion of early infection. Therapeutic measures: puncture, anticoagulation therapy, pt, medication. An additional medical intervention was necessary. Additional information was not provided nor available. Additional patient information is not available. The adverse event is filed under (b)(4). Involved components: nx057k - vega ps tibial plateau cemented t4 - 52360588a, nx140 - vega ps gliding surface t4/4+ 10mm - 52421371, nx033k - vega ps femoral component cemented f6n r - 52530600.

• Brand Name: ORTHOPILOT BASIS COMPACT
• Type of Device: ORTHOPILOT NAVIGATION SYSTEM
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9728660
• MDR Text Key: 182298452
• Report Number: 9610612-2019-00953
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K080547
• 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,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: FS101
• Device Catalogue Number: FS101
• Device Lot Number: 51589952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2009
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 02/19/2020 Patient Sequence Number: 1