MAUDE Adverse Event Report: ZIMMER CAS ROSA RECON PLATFORM 110V; ROBOTIC SURGICAL ARM SYSTEM

Catalog Number	20-8020-100-01
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as its evaluated-on site.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during surgery the system aggressively pulled away from the patient.This was not like the drift that has been seen in the past.During corrective maintenance, it was discovered that the force torque sensor and cable were worn.The robot arm was drifting and resisting during the arm accuracy test.There was no harm or impact to the patient.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: a1, b4, b5, d4, e1, e2, e3, g1, g2, g3, g6, h1, h2, h3, h6, and h11.Corrected: g4 (510k).Physical and technical evaluation was performed by a field service engineer (fse).The fse confirmed the reported issue of robotic arm drifting and observed it during the arm accuracy test.The fse replaced the ft sensor, ft sensor to robot arm cable, noting they were worn, and the daq card, correcting the issue.Medical records were not provided.The serial number was reviewed for any deviations and/or anomalies in the servicing/maintenance process that may have contributed to this reported event.No deviations or anomalies were discovered; therefore, it is not expected that the servicing/maintenance process contributed to the reported issue.The device was previously serviced and the system was found to be in working order.The root cause cannot 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ROSA RECON PLATFORM 110V
• Common Device Name: ROBOTIC SURGICAL ARM SYSTEM
• Manufacturer (Section D): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec
• Manufacturer (Section G): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22167570
• Report Number: 0009617840-2025-00022
• Device Sequence Number: 13141753
• Product Code: OLO
• UDI-Device Identifier: 00889024511170
• UDI-Public: (01)00889024511170(11)190719
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K242864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 20-8020-100-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown