MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN MAKO LEFT MEDIAL POLY INSERT; KNEE IMPLANT

Catalog Number UNK_OFL

Device Problem Insufficient Information (3190)

Patient Problems Arthritis (1723); Injury (2348)

Event Date 08/30/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding instability involving an unknown insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned for evaluation.Medical records received and evaluation: a review of the provided medical records x-rays by a clinical consultant indicated: " - x-ray prevision confirms progression of osteoarthritis in the other 2 compartments of a patient with a uni knee insitu; additional information needed such as operative reports, clinical past medical history, etc".Device history review could not be performed as the device lot is unknown.Complaint history review could not be performed as the device lot is unknown.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, return of device, operative reports, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.Not returned.

Event Description

It was reported that patient's left knee was revised from a medial uni knee to a ps total knee due to instability.Rep reported cause of instability was disease progression of patient's existing condition of osteoarthritis.

• Brand Name: UNKNOWN MAKO LEFT MEDIAL POLY INSERT
• Type of Device: KNEE IMPLANT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7916373
• MDR Text Key: 121991159
• Report Number: 3005985723-2018-00552
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR