MAUDE Adverse Event Report: ZIMMER CAS ROSA PERSONA TKA CUT GUIDE A; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a tka surgery and the cuts performed on the tibia and femur resections were 3mm off (overcut) from planned resection values.The procedure was completed using a larger poly with no known impact or consequence to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Zimmer biomet complaint : (b)(4).This final report is being submitted to relay corrected and additional information.Summary: technical review and physical evaluation: subject matter expert log analysis of the reported event, confirmed ¿the femur resection and cut block.But the log do not confirm the tibia resection.The femur over-resection was confirmed by the validation data both on the medial and lateral resection.The over-resection was also confirmed with a caliper measurement.The tibia resection.The logs do not reveal any registered validation data for the tibia cut.The live cut values and the validation tool are visible to the camera toward the end of the resection flow.It is possible that the user saw the validated value and simply did not accept them.Unfortunately, this means the value seen on screen was not recorded in the logs.The cut block would not passing checkpoint validation: technical and physical inspection of the cut block showed crushed threads at one of the two thumbs screws along with excessive wear at the cut slots areas.It was deemed non-conform by the manufacturing team.This could have affected the mounting of the cut block and resulted in the checkpoint failures.Others factors contributed to the reported event: femur and tibia 3mm over-resection: change of orientation of the camera, or change of orientation of the base tracker.The second registration might have been affected by non-optimal mounting of the arm reference, an instability of the robot or camera, preventive maintenance, software and hardware upgrade was performed by a field service technician on (b)(6) 2021, robotic system was tested as per procedure, all tests passed successfully.No device or software issues were found.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause: a precise root cause for reported resections discrepancies cannot be determined.Probable cause is robot base tracker movement.Other potential factors include: damaged or worn cut block; instability of the robot camera; an unusual landmarking section and a movement of the bone tracker; erroneous landmarks on a generic bone model; poor six-point registration; defective validation tool/loose validation tool tracker/validation tool not mounted correctly.A precise root cause for reported checkpoint failure for cut guide cannot be determined.Although the cut guide was found to be damaged through use by zimmer staff, a probable root cause is a movement of robot base tracker.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 or Problem Description
It was reported that a patient underwent a robotic assisted tka surgery and the cuts performed on the tibia and femur resections were 3mm off (overcut) from planned resection values due to a defective cutting block.The procedure was completed using a larger poly with no known impact or consequence to the patient.Attempts have been made and no further information has been provided.

• Brand Name: ROSA PERSONA TKA CUT GUIDE A
• Common Device Name: 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 CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12624672
• Report Number: 0009617840-2021-00022
• Device Sequence Number: 11647115
• Product Code: OLO
• UDI-Device Identifier: 00889024505179
• UDI-Public: (01)00889024505179(10)J190690
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K182964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8020-007-00
• Device Lot Number: J190690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White