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

Catalog Number UNK_OFL

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 07/20/2020

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.Device not returned.

Event Description

This pi is for patient 4 of 10.Surgeon reported he is experiencing a high complication rate with patients whose primary procedures were mako procedures.The nature of the 10 cases is unknown at the time of report.Complications reported include effusions, pain, stiffness, possibly requiring 'scopes' and/ or poly exchanges.The nature of intervention for each of the 10 patients is unknown.

Manufacturer Narrative

Updated the mdr and mir codes.Reported event.An event regarding pain/ complications involving an unknown mako was reported.The event was not confirmed.Method & results.-product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: not performed as the device lot details were not provided.-complaint history review: not performed as the device lot details were not provided.Conclusions: it was reported complications with ten mako primary procedure patients were noticed; this pi is for patient 4 of 10.Complications reported include effusions, pain, stiffness, possibly requiring 'scopes' and/ or poly exchanges.Details of the complications for this specific patient were not reported.The nature of intervention for this specific patient is unknown.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

This pi is for patient 4 of 10.Surgeon reported he is experiencing a high complication rate with patients whose primary procedures were mako procedures.The nature of the 10 cases is unknown at the time of report.Complications reported include effusions, pain, stiffness, possibly requiring 'scopes' and/ or poly exchanges.The nature of intervention for each of the 10 patients is unknown.

• 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: 10396146
• MDR Text Key: 202548792
• Report Number: 3005985723-2020-00256
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention