MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 4-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180704-1

Device Problems Material Integrity Problem (2978); Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Discomfort (2330); Injury (2348); Inadequate Osseointegration (2646)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted if additional information becomes available.

Event Description

Revision of mako left medial knee.Femoral component was loose although not grossly.Abnormal wear on the tibial insert.

Manufacturer Narrative

An event regarding alleged "wear" involving a mck tibial onlay insert-sz 4-8 mm was reported.The event was confirmed.Method & results: -device evaluation and results: a material analysis was performed and indicated "burnishing, scratching and third-body indentations were observed on the articulating surface of the insert.These are common damage modes of uhmwpe.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: not performed as medical records were not received for review with a clinical consultant.-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 root cause could not be determined because insufficient medical information was provided.A material analysis was performed and indicated "burnishing, scratching and third-body indentations were observed on the articulating surface of the insert.These are common damage modes of uhmwpe.No material or manufacturing defects were observed on the surfaces examined." if additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Revision of mako left medial knee.Femoral component was loose although not grossly.Abnormal wear on the tibial insert.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 4-8MM
• 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: 6225578
• MDR Text Key: 63957229
• Report Number: 0002249697-2017-00085
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 180704-1
• Device Lot Number: 12140513-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2013
• 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
• Patient Age: 56 YR