MAUDE Adverse Event Report: ZIMMER CAS ROSA RECON PLATFORM 220V; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/10/2022

Event Type  Injury  

Event Description

It was reported that during a tka procedure using rosa knee instrumentation, the patient's proximal tibia was over-resected and the 4-in-1 posterior femur was under resected.This lead to an anterior femur notch, although it was warned as potentially an issue.Surgeon decided to proceed.All bone chips were calipered.There was no additional patient impact reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Same/similar to rosa unit 510(k): k182964.Report source, foreign - event occurred in (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that during a tka procedure using robotic instrumentation, the patient's proximal tibia was over-resected and the 4-in-1 posterior femur was under resected.This lead to an anterior femur notch, although it was warned as potentially an issue.Surgeon decided to proceed.All bone chips were calipered.There was no additional patient impact reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Zimmer biomet reference (b)(4).Same/similar to product 510(k): k182964.G2: report source, foreign - event occurred in australia.This final report is being submitted to relay additional information from the completed investigation.Evaluation results: a subject matter expert (sme) evaluated the log files of the case and was unable to confirm the distal resection, 4in1 resection, and tibia resection due to the lack of validation.The sme was able to determine several possible root causes that may have contributed to the observed cut value discrepancy.Change of orientation of the base tracker in the camera¿s eye occurred before the distal flow and between the 4in1 and tibia resections.Could be a contributive factor for both discrepancies.Unusual landmarking of the femur posterior condyle and tibia plateaus could have a minor contribution.Without seeing the validation, their impact is difficult to evaluate.Movement of the bone versus cut guide may also be a small contributive factor.Some of the 4in1 cut values were off target and the tibia tracker was not visible for a good portion of the tibia resection.Movement of the bone references/trackers could be a potential issue.The trackers stability during the stationary modes was good when they were visible and the final knee evaluation does not present any aberrant values.However, the ml distance between the femur and tibia navitracker varies a lot during the final knee evaluation and differs from initial knee evaluation.This could be due to the trial of multiple implant sizes which seems to be corroborated by the multiple resets done by the user.As none of the cuts were validated, the stability of bone references/trackers cannot be assessed.Unplanned flexion on the distal resection impact on the 4in1 resection cannot be evaluated since no validation was done on the distal cut.It could still be a contributive factor.There were no software anomalies identified which would have caused or contributed to the reported event.The system responded as expected.Dhr review: dhr was reviewed and no discrepancies related to the reported event were found.Complaint history review: a complaint history review was conducted.The search identified three (3) additional complaints for the same serial number that was for the same or similar issue within one (1) year prior to the notification date of this complaint (10 february 2022 ).The search identified fourteen (14) additional complaints reported for this device within one (1) year prior to the notification date of this complaint (feb 10th, 2022) and thereafter for the same or similar issue.Root cause: 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.

• Brand Name: ROSA RECON PLATFORM 220V
• 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 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: 13711615
• MDR Text Key: 291615844
• Report Number: 0009617840-2022-00013
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• 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,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8020-100-26
• 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: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female