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

Model Number N/A

Device Problem Output Problem (3005)

Patient Problem No Code Available (3191)

Event Date 09/21/2020

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.Hospital owns the product.

Event Description

It was reported that femoral notching occurred during a robotic assisted total knee arthroplasty.No additional patient injury was reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected 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 rosa knee system software application log files detected no error system in logs the potential cause for notching is due to the femoral tracker movement during surgery.There is no indication in the logs that points to a software or system error for the femoral cut.The system had no issue during registration or during resection of the tibia.This rosa knee system was evaluated on site by a field service engineer and found no fault with the 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.

Event Description

No additional information reported.

• 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: 10778568
• MDR Text Key: 214791562
• Report Number: 0009617840-2020-00006
• 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
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• 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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other