MAUDE Adverse Event Report: ZIMMER CAS ROSA KNEE PLATFORM JP PL B; ROBOTICS, KNEE

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2023

Event Type  malfunction  

Event Description

It was reported that collision error appeared many times in the process of feeding cut block at tka work shop although the surgeon confirmed nothing was wrong with cables around the sensor.No additional information.

Manufacturer Narrative

(b)(4).G2: foreign country: japan reported event was confirmed by review of investigation logs.Investigation log files of the reported error were provided with the per submission, reviewed by a subject matter expert, and confirmed the reported event.The logs confirmed collision errors were detected during the procedure.The issue was found to be hardware related.A communication cable to the f/t sensor was defective.There was no indication in the logs that a software defect or anomaly caused or contributed to the reported event.The field service engineer visited the hospital and found that ft sensor cable had a problem.The fse replaced the cable.After that, it was confirmed that the arm operated without any drift or collision in the accuracy test of the arm and the osteotomy operation test.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause for the failed hardware component (ft sensor cable) could not be determined with the information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ROSA KNEE PLATFORM JP PL B
• Type of Device: ROBOTICS, KNEE
• 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: kristen lashley ; 56 e. bell dr.; warsaw, IN 46582 ; 9016334069
• MDR Report Key: 18328804
• MDR Text Key: 330576673
• Report Number: 0009617840-2023-00024
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K210121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 20-8020-100-17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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): Other