MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	209999
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	07/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
Leg length discrepancy.Surgeon would like to have report done.Case type / application: tha 4.1 update as per mps response on 25 july 2024: additional information received, "1.What is the surgeon¿s plan for this patient? unknown 2.Which side was the operative side? left 3.Is the operative side longer or shorter than the other side? longer 4.Length of discrepancy (mm): approximately 10mm".
Additional Manufacturer Narrative
Reported event: an event regarding inaccurate reaming involving a mako tha software was reported.The event was not confirmed because the product was not available for inspection.Method & results: product evaluation and results: the alleged failure mode cannot be determined because the relevant log files and session files were not available for inspection.A request for a field service engineer inspection was not made and the robot was not inspected as no service max case & work order exists and tech service report is provided by the complainant.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that rob was inspected and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints in trackwise, shows no other complaints related to the failure in this investigation.Conclusions: the alleged failure mode cannot be determined because the relevant log files and session files were not available for inspection.A request for a field service engineer inspection was not made and the robot was not inspected as no service max case & work order exists and tech service report is provided by the complainant.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
Leg length discrepancy.Surgeon would like to have report done.Case type / application: tha 4.1.Update as per mps response on 25 july 2024: additional information received, "1.What is the surgeon¿s plan for this patient? unknown.2.Which side was the operative side? left.3.Is the operative side longer or shorter than the other side? longer.4.Length of discrepancy (mm): approximately 10mm".

• Brand Name: 3.0 RIO ROBOTIC ARM - MICS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20263778
• Report Number: 3005985723-2024-00161
• Device Sequence Number: 8261720
• Product Code: LPH
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2013
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown