MAUDE Adverse Event Report: Zimmer CAS ROSA RECON PLATFORM 110V; Orthopedic Stereotaxic Instrument

Catalog Number	20802010001
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rosa knee procedure, the robotic arm drifted after the 4-in-1 cuts.Subsequently, the surgeon completed the procedure using manual instrumentation.There was no adverse patient outcome.Follow-ups to gather additional information are currently in process.
Additional Manufacturer Narrative
(b)(4) the reported robotic unit remains onsite with the customer and will be evaluated by a field service engineer.Once the investigation has been completed, a supplemental mdr will be submitted.

• Brand Name: ROSA RECON PLATFORM 110V
• Common Device Name: Orthopedic Stereotaxic Instrument
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50855312
• Report Number: 0009617840-2026-00022
• Device Sequence Number: 9923520
• Product Code: OLO
• UDI-Device Identifier: 00889024511170
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K251314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 20802010001
• Was Device Available for Evaluation?: No
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male