MAUDE Adverse Event Report: ZIMMER CAS ROSA RECON PLATFORM 220V; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number N/A

Device Problem Output Problem (3005)

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

Event Date 10/10/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent a robotic assisted tka surgery and the cuts performed on the tibial resections were around 4-4.5 mm off (overcut) from planned resection values.The procedure was completed using a larger poly (14mm) than planned (10mm) with no known reported impact to the patient.Patient was pain free and discharged 3 days post op.It was reported that no additional information is available regarding this incident.

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).This product is same or similar to pma/510(k) number: k182964.Country of origin: (b)(6).This event was previously submitted on nov 8th under mfr report: 0001822565-2021-03207.The event is being resubmitted under this initial report to correct the mfr number and corresponding manufacturing information.Updated fields from mfr: 0001822565-2021-03207.Country of origin: (b)(6).All necessary information needed for the investigation has been provided and an investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a robotic assisted tka surgery and the cuts performed on the tibial resections were around 4-4.5 mm off (overcut) from planned resection values.The procedure was completed using a larger poly (14mm) than planned (10mm) with no known reported impact to the patient.Patient was pain free and discharged 3 days post op.It was reported that no additional information is available regarding this incident.

Manufacturer Narrative

Zimmer biomet complaint : (b)(4).This product is same or similar to pma/510(k) number : k182964.Country of origin : australia.This follow-up report is being submitted to relay additional information.Evaluation summary the robotic system's software application log files and pictures were sent back for investigation.Investigation of the log files confirmed the reported event of resection value discrepancy.In this particular case the following potential causes are the most probable: - movement of the leg, or bone tracker, relative to the cut guide during resection - movement of the robot base or robot base tracker the functionality and accuracy of robotic system was verified on oct 22, 2021 by a field service technician through the following tests: - robotic arm accuracy verification - camera accuracy verification - robotic applicative test all of the tests passed and no issues related to the reported issue were found.The reported event is not considered to have been caused by malfunction of the robotic system.A dhr review was performed and indicated that there was no issue linked to the reported event.The instruments are confirmed to have met specifications and were determined to be conforming when they left zimmer biomet control.A definitive root cause could not be determined but probable causes have been identified.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ROSA RECON PLATFORM 220V
• Type of Device: 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13994709
• MDR Text Key: 288481678
• Report Number: 0009617840-2022-00016
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• 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,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8020-100-26
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other