MAUDE Adverse Event Report: ZIMMER CAS ROSA RECON PLATFORM 220V; ROBOTICS, KNEE

Model Number N/A

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2023

Event Type  malfunction  

Event Description

It was reported that the rosa was giving an unknown robotic error.The customer tried reseating of force sensor to robot arm cable.No additional information.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of investigation logs and onsite investigation.Investigation log files of the reported error were provided with the per submission, reviewed by a subject matter expert, and confirmed the reported event.The robotic errors were observed in the log files most likely caused by a micro disconnect of the starc card.There was no indication in the logs that a software defect or anomaly caused or contributed to the observed error.A field service engineer (fse) was onsite to investigate the robot.The engineer observed an unknown robotic error.The fse reseated the starc card.Device history record (dhr) was reviewed and no discrepancies were found.The cause for the observed errors was a disconnection/loosening of the starc card.However, definitive root cause for the loosening/disconnection could not be determined with the information available.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ROSA RECON PLATFORM 220V
• Type of Device: ROBOTICS, KNEE
• Manufacturer (Section D): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer (Section G): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer Contact: kristen lashley ; 56 e. bell dr.; warsaw, IN 46582 ; 9016334069
• MDR Report Key: 18237051
• MDR Text Key: 329366923
• Report Number: 0009617840-2023-00022
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K210121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8020-100-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1