MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL-RM-LL-SZ 4; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180514

Device Problem Loss of Osseointegration (2408)

Patient Problem Pain (1994)

Event Date 07/24/2013

Event Type  Injury  

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.

Event Description

This is a (b)(6) year old male who presents with the complaint(s) of 1.5 years s/p r med (b)(4) with (b)(6) on (b)(6) 2011 at (b)(6) hospital.Was doing well until 6 mos post op, was struck by a wave at the beach and has had pain since.Pain descending stairs.A lot of pain when off celebrex.No swelling, warmth, drainage.

Manufacturer Narrative

An event regarding loosening involving a mako femoral component was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated that: "no x-ray or bone scan images or reports, no examination of the explanted components, no confirmation of the loose femoral component, and no follow-up subsequent to the (b)(6) 2013 examination six weeks post-revision of the femoral component are available.Based upon the information available for review, there is no indication that factors related to implant design, manufacturing or materials were responsible for this clinical situation." -device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Provided medical information was submitted to a consulting clinician who indicated that no confirmation of the loose femoral component and there is no indication that factors related to implant design, manufacturing or materials were responsible for this clinical situation.No further investigation is required at this time.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

This is a (b)(6) male who presents with the complaint(s) of 1.5 years s/p r med uka with rob on (b)(6) 2011 at (b)(6).Was doing well until 6 mos post op, was struck by a wave at the beach and has had pain since.Pain descending stairs.A lot of pain when off celebrex.No swelling, warmth, drainage.

Event Description

This is a (b)(6) year old male who presents with the complaint(s) of 1.5 years s/p r med uka with rob on (b)(6) 2011 at (b)(6) hospital.Was doing well until 6 mos post op, was struck by a wave at the beach and has had pain since.Pain descending stairs.A lot of pain when off celebrex.No swelling, warmth, drainage.

• Brand Name: MCK FEMORAL-RM-LL-SZ 4
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6441973
• MDR Text Key: 71100540
• Report Number: 3005985723-2017-00153
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Catalogue Number: 180514
• Device Lot Number: 14650609-7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2011
• 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): Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 93