MAUDE Adverse Event Report: ZIMMER CAS ROSA RECON PLATFORM 110V; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	20802010001
Medical Device Problem Codes	Unintended System Motion (1430); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An investigation into the reported malfunction is in process.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that during a rosa knee case, a forces sensor error and unintended robotic arm drifting was experienced.No harm or impact reported.Investigation logs found faulty ft sensor cable and daq card causing drifting intermittently.A field service engineer went on site to replace the faulty daq card and cable.The engineer confirmed the new daq card in nimax, ft sensor tested, arm accuracy test, and applicative test all passed.The unit is fully functional.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1; a2; a3; b5; e1; e2; e3; g3; h2; h6.An investigation into the reported malfunction is in process.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that during a rosa knee case, a forces sensor error and unintended robotic arm drifting was experienced.The procedure was completed utilizing the robot with no further issues.A slight delay occurred once a calibration error appeared, but it was cleared and the case proceeded.No patient impact.Investigation logs found faulty ft sensor cable and daq card causing drifting intermittently.A field service engineer went on site to replace the faulty daq card and cable.The engineer confirmed the new daq card in nimax, ft sensor tested, arm accuracy test, and applicative test all passed.The unit is fully functional.

• Brand Name: ROSA RECON PLATFORM 110V
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec
• 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 ; 5745260384
• MDR Report Key: 24998727
• Report Number: 0009617840-2026-00015
• Device Sequence Number: 15340712
• Product Code: OLO
• UDI-Device Identifier: 00889024511026
• UDI-Public: (01)00889024511026(11)250414
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2026

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: 04/01/2026
• Supplement Date Received by Manufacturer: 04/27/2026; 05/18/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 04/27/2026; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female