MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number UNK_OFL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 01/27/2021

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.Device not returned.

Event Description

It was reported that a stage 1 revision on a right mako knee implanted (b)(6) 2020 was performed due to a staph infection.All components were removed and implants used as a spacer were placed.Rep provided primary and revision usage and a picture of the explants, and confirmed that no further information will be released by the hospital or surgeon.

Event Description

It was reported that a stage 1 revision on a right mako knee implanted on (b)(6) 2020 was performed due to a staph infection.All components were removed and implants used as a spacer were placed.Rep provided primary and revision usage and a picture of the explants, and confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding infection involving an unknown mako robot/tka software was reported.The event was not confirmed because the product was not available for inspection.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 could not be performed as the device was not properly identified.Complaint history review: a review of complaints in trackwise could not be performed as the device was not properly identified.Conclusions: the alleged failure mode was not confirmed because the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• Brand Name: UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 11350803
• MDR Text Key: 232856964
• Report Number: 3005985723-2021-00027
• Device Sequence Number: 1
• Product Code: OLO
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 113