MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL- LM-RL- SZ 7; IMPLANT

Catalog Number 180507

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 05/27/2015

Event Type  Injury  

Event Description

B.M.Revised a left medial mako pka originally done on (b)(6) 2012 to a stryker triathlon cementless.(b)(6) claimed the patient formed lateral compartment disease.The mako pka implants were well fixed he noted.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the hospital and was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Manufacturer Narrative

Review of device history records indicates the lot was manufactured and accepted into final stock on 30-jun-2011.A complaint history review was not performed as the indication for revision was not provided; no device specific failure modes were identified.The event could not be confirmed nor the root cause of the reported revision surgery determined due to the minimal information received.The clinical indication for the revision was not provided.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

(b)(6) revised a left medial mako pka originally done on (b)(6) 2012 to a stryker triathlon cementless.(b)(6) claimed the patient formed lateral compartment disease.The mako pka implants were well fixed he noted.

• Brand Name: MCK FEMORAL- LM-RL- SZ 7
• Type of Device: 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4860488
• MDR Text Key: 22251864
• Report Number: 3005985723-2015-00107
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2015

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 Expiration Date: 06/30/2016
• Device Catalogue Number: 180507
• Device Lot Number: 26220511-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 06/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2011
• 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): Required Intervention