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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).This incident was deemed reportable for device malfunction after the investigation results were made available to complaint handler on 16-nov-2021.Rosa camera accuracy verified from the investigation log files.All setup steps for rosa surgery occurred without issue.Onsite representative reported reported by email that the cut guide was not positioned in the same position relative to the bone as in the first cut on the tibial resection.This information indicated a movement of the bone navitracker relative to the cut guide.This suggest a retractor was put in place after pinning cut guide instead of before as recommended by surgical technique.Review of the dhr for p/n 20-8020-100-01, s/n (b)(4) (rosa recon platform us pl b) identified no deviation and/or anomalies related to the reported complaint event.A definitive root cause was unable to 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 a tka rosa cut validations were off from planned tibial values by 4mm on medial and lateral sides.Upon completion of the investigation into this incident and reassessment of the complaint it was determined that over resection of 4mm had occurred on tibia.The procedure was completed with no known impact or consequence to the patient.Attempts have been made and no further information has been provided.

• 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
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12984829
• MDR Text Key: 282126108
• Report Number: 0001822565-2021-03500
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• 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