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

Model Number N/A

Device Problem Output Problem (3005)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 06/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a knee arthroplasty utilizing the robotically assisted surgical system, rosa, the tibial cut was reported to be too varus.The tibia was re-cut using standard instrumentation.No additional patient consequences were reported.

Manufacturer Narrative

The reported event could not be confirmed.The log files investigation revealed that no varus/valgus discrepancy was found between the intra-operative plan and validation for all the cuts performed with rosa robot system.Applicative tests were performed during preventive maintenance with no issues found; the functionality and accuracy of rosa knee platform device history record was reviewed and no discrepancies relevant to the reported event were found.The device functioned as intended.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 ROBOTIC UNIT 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: 8813780
• MDR Text Key: 151848555
• Report Number: 0009617840-2019-00005
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

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: 06/25/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention