MAUDE Adverse Event Report: ZIMMER CAS ROSA KNEE PLATFORM US PL B; ROBOTICS, KNEE

Model Number N/A

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Event Description

It was reported the rosa continued to give an error message.A hard reset was attempted multiple times.The device was unplugged and the loading of other cases was attempted.It was suspected that a fuse between the robot and computer may have been the issue.No additional information.

Manufacturer Narrative

(b)(4).G2: foreign country: canada.The reported event was confirmed by an onsite investigation.A field service engineer was onsite to investigate the robot.The engineer observed a defective starc card that was causing the reported issue.The fse replaced the starc card and swapped the slot.Following the repair, the unit was confirmed to be in working order.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause for the failed hardware component (starc card) could not be determined with the information.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 KNEE PLATFORM US PL B
• 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: 18318528
• MDR Text Key: 330382845
• Report Number: 0009617840-2023-00023
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K210121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• 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: 20-8020-100-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2021
• 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
• Patient Outcome(s): Other