MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209999

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 10/08/2020

Event Type  Injury  

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 when additional information becomes available.

Event Description

This pi is for the 08/october/2020 revision.As reported: "dr.Performed an i&d of a triathlon knee due to infection.Original dos was (b)(6) 2020 with mako.The patient was originally revised on (b)(6) 2020 with an i&d insert exchange due to infection.Today ((b)(6) 2020) the patient presented with other health issue after stopping oral meds and (b)(6) decided to start over with the treatment by performing another i&d insert exchange.Right knee." a 4x9 cs insert was revised to another 4x9 cs insert.Rep provided usage sheets for primary procedure and both revisions, and confirmed that no further information will be released by the hospital or surgeon.

Event Description

This pi is for on (b)(6) 2020 revision.As reported: "dr.Performed an i&d of a triathlon knee due to infection.Original dos was on (b)(6) 2020 with mako.The patient was originally revised on (b)(6) 2020 with an i&d insert exchange due to infection.Today (on (b)(6) 2020) the patient presented with other health issue after stopping oral meds and on (b)(6) and decided to start over with the treatment by performing another i&d insert exchange.Right knee." a 4x9 cs insert was revised to another 4x9 cs insert.Rep provided usage sheets for primary procedure and both revisions, and confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding infection involving a mako tka software / robot was reported.The event was not confirmed.Method & results: product evaluation and results: review of the case session files was not performed as case session data was not provided.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that (b)(6) was inspected on 21 sept 2011 and the quality inspection procedures were completed with no reported discrepancies complaint history review: a review of complaints in trackwise related to p/n: 209999, robot number: (b)(6) shows 3 similar complaints for tka software - other (infection).Conclusions: the alleged failure mode was not confirmed.It was reported that the patient was revised due to infection.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 106 in accordance to applicable iso standards.The event could not be confirmed nor the exact cause be determined because insufficient information was provided.  no further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

• Brand Name: 3.0 RIO ROBOTIC ARM - MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10785410
• MDR Text Key: 214571267
• Report Number: 3005985723-2020-00336
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR