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 08/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.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.

Event Description

It was reported that during a robotic assisted total knee arthroplasty there was a discrepancy between the planned and validated right femoral cuts.The procedure was delayed approximately 25 minutes.No additional patient impact reported.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Evaluation summary: the rosa knee system software application log files were sent back for investigation.Investigation of the log files confirmed the reported event of resection value discrepancy.The investigation revealed that all setup steps ran without issue and that the femur and tibia landmarks were acquired a first time without issue, as well as the initial knee evaluation.The user retook all tibia and femur landmarks without issue, as well as an intra-op knee evaluation that showed results (gaps, varus/valgus opening) quite different from the initial knee evaluation.During the femoral distal resection, three validations were made while the cut guide was still pinned to the bone.All three validations are coherent one with another.Logs confirm the planned and validated values raised in the complaint.However, the reported caliper measurement could not be confirmed in the logs.Pictures of the caliper measurements were not provided for evaluation.Positions of robot base tracker in camera were analyzed and show that many major displacements occurred during surgery.Based on the timing of those movements, it should have a minor impact on the observed discrepancy.The functionality and accuracy of rosa recon platform s/n (b)(6) (p/n 20-8020-100-26) was verified on (b)(6), 2021 through the following tests: - rosa arm accuracy verification.- camera accuracy verification.- rosa knee 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 rosa knee system.Review of the log files did not find evidence that a software error caused or contributed to the reported event.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.

Event Description

It was reported that during a robotic assisted total knee arthroplasty there was a discrepancy between the planned and validated right femoral cuts.The procedure was delayed approximately 25 minutes.No additional patient impact reported.

• 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: 12438669
• MDR Text Key: 270286467
• Report Number: 0009617840-2021-00021
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K182964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Event Location: Hospital
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• 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): Required Intervention; Other