MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MAKO ROBOTIC ARM 3.1; STEREOTAXIC DEVICE, ROBOTICS

Model Number 219999

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injection Site Reaction (4562)

Event Date 10/01/2020

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

It was reported through the submission of a revision usage sheet that the patient's right knee was revised.A 2x11 ts insert was implanted.Update 05/october/2020 wg: sales branch provided the primary usage sheet.A 2x9 ts insert was revised to a 2x11 ts insert.Update: "patient was treated with i&d due to acute infection.X-rays/removed polyethylene are not available.".

Manufacturer Narrative

Reported event an event regarding infection involving a mako tka software 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 rob880 was inspected on 13 feb 2019 and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints in trackwise related to p/n 219999, robot number: rob880 shows 0 similar complaints for tka software - other(infection).Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as pre- and post-op x- rays, patient history, pathology report & follow-up notes are needed to investigate this event further.Infection is a known possible adverse outcome of surgery, as noted in the instructions for use.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.If additional information and/or device becomes available, this investigation will be reopened.H3 other text : device not returned.

Event Description

It was reported through the submission of a revision usage sheet that the patient's right knee was revised.A 2x11 ts insert was implanted.Update (b)(6)2020 wg: sales branch provided the primary usage sheet.A 2x9 ts insert was revised to a 2x11 ts insert.Update: "patient was treated with i&d due to acute infection.X-rays/removed polyethylene are not available.".

• Brand Name: MAKO ROBOTIC ARM 3.1
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10762456
• MDR Text Key: 213878995
• Report Number: 3005985723-2020-00330
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 219999
• Device Catalogue Number: 219999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR