MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK PATELLOFEMORAL-L-SZ 4; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number 180404

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient underwent mako tka revision from mako pf due to progressive oa.

Manufacturer Narrative

An event regarding patient factors involving a mako patellofemoral component was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there has been no other similar events for the reported lot.Conclusion: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Patient underwent mako tka revision from mako pf due to progressive oa.

• Brand Name: MCK PATELLOFEMORAL-L-SZ 4
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8329924
• MDR Text Key: 135860497
• Report Number: 3005985723-2019-00128
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000424
• UDI-Public: 00848486000424
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

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: 08/30/2020
• Device Catalogue Number: 180404
• Device Lot Number: 237407-1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 03/28/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention