MAUDE Adverse Event Report: ZIMMER CAS ROSA KNEE PLATFORM US PL B; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number N/A

Device Problem Imprecision (1307)

Patient Problem No Code Available (3191)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 a robotic assisted total knee arthroplasty the patient's femoral bone was notched more than 5mm.No additional information has been received.

Event Description

No additional information reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Post-op x-ray images of the operated knee confirmed the reported event of the rosa knee system procedure resulting in a notching of the femur of more than 5mm.Investigation of the log files by a software sme found that during the surgery the landmarks of the anterior femoral cortex were positioned more medially than what is expected; the landmarks seem to be in the trochlea instead of being on these sides.The patient's trochlea dysplasia could have influenced this stage, but this cannot be verified remotely.After identifying the error on the resection, the system was used to modify the surgical plan.As the notching calculation is largely based on the landmarks of the femoral anterior cortex, the notching could not be precisely calculated and the surgeon did not receive a warning of potential notching.There is no indication in the logs that points to a software error, or explains an error on the part of the system for this cut.All the trackers behaved normally and the system had no issue during registration or during resection of the tibia.The rosa knee system was evaluated on site by a field service engineer (fse) and found no fault with the system.The reported events are not considered to have been caused by the rosa knee 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.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 KNEE PLATFORM US PL B
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• MDR Report Key: 10485049
• MDR Text Key: 205539037
• Report Number: 0009617840-2020-00004
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K182964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

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: 20-8020-100-01
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 09/18/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other