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

Model Number N/A

Device Problem Output Problem (3005)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that during robotic assisted total knee arthroplasty the patient experienced approximately 1-2mm of femoral notching.There was no additional patient impact reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This final report is being submitted to relay additional information from the completed investigation.Evaluation summary: the analysis log files associated with the reported event not confirm the event but the provided post-op x-rays do.Through information exchange between sme and zimmer rep, the following was confirmed: -the surgeon performed the anterior chamfer cut, he noticed that he had removed too much bone and notched the anterior cortex and proceeded with the case.-when trialing the size 7, there was a space anterior, so downsizing the femur to a 6 was suggested.The 6 was a better fit, however there was still space when cementing the implant and the surgeon used a small piece of bone between the implant surface to improve the fit through review of logs, sme noticed the following: -initial knee evaluation, surgery started with the femur distal resection.The two validations show a loss of flexion angle and the validated values are slightly under target.This could be due to a mild case of skiving on this femoral resection.-during 4in1 resection was next.Of particular interest in this case is the resizing of the femoral implant.The pre-operative and initial planning used a size 8 implant.At this point of the surgery, user changed to a size 7.The femoral implant used in this surgery is posterior referenced.This brought down the stylus height.- a second 4in1 resection was performed: at first sight, it was unclear if the holes were drilled during the first resection or not, the timing both flow is nearly identical.Which indicate that the first holes were drilled.This was confirmed by the representative.The posterior resections were increased.This brought the stylus height back up.- there was a collision detected a few seconds after the completion of the 4in1 surgical flow.It occurred after all the femoral cuts were completed, -after the trial implants were tested, user changed the femoral implant size down to a size 6.The implant size down by one with a posterior reference will diminish the stylus height.While there is no planning with this size 6 implant, the stylus height should still be within a certain range.This value is in line with the reported planning of the complaint description.Dhr review: review of the dhr identified no deviations or anomalies related to the reported event.Complaint history review: a complaint history review was conducted for part numbers ¿20-8020-110¿ and ¿208020110¿.The search identified no additional complaint for the same serial/lot number ((b)(6)) that was for the same or similar issue.The search identified three (3) additional complaints reported for this device ¿20-8020-110¿ within one (1) year prior to the notification date of this complaint (sept 14, 2021) and thereafter for the same or similar issue.As the severity of harm is 1, the results do not indicate a need for further evaluation.Complaints are tracked and trended on a monthly basis per qi09-03.Root cause: a definitive root could not be determined.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 robotic assisted total knee arthroplasty the patient experienced approximately 1-2mm of femoral notching.There was no additional patient impact reported.Attempts have been made and no further information has been provided.

• Brand Name: ROSA RECON ROBOTIC UNIT 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: 12614815
• MDR Text Key: 276359307
• Report Number: 0009617840-2021-00023
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8020-110-26
• 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: 09/14/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability