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 Problem Unspecified Infection (1930)

Event Date 03/16/2020

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

As reported for patient's right knee: "swapped out the poly today due to infection.No x-rays available, no other information available due to hospital policy.".

Event Description

As reported for patient's right knee: "swapped out the poly today due to infection.No x-rays available, no other information available due to hospital policy.".

Manufacturer Narrative

Reported event: it was reported ¿as reported for patient's right knee: "swapped out the poly today due to infection.No x-rays available, no other information available due to hospital policy." product evaluation and results: review of the case session files was not performed as case session data was not provided.Product history review: a review of device history records shows that rob158 was inspected on (b)(6) 2011 and was handled.A review of the data revealed that the non-conformances is not related to the failure alleged in this complaint.Complaint history review: a search of the complaint database under device identification pn (b)(4) reports no similar complaints for tka software, other.Conclusions: the failure could not be determined as no case session data or logs were provided after three communication attempts were made.No additional investigation or specific actions are required.If additional information is received then the complaint 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: 10142582
• MDR Text Key: 194772933
• Report Number: 3005985723-2020-00213
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR