MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 3-10MM; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number 180703-3

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding revision surgery involving a mako insert was reported.The event was confirmed as a revision implant sheet was provided for review.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; all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Additional devices listed in this event: catalog: 180603, description: mdk tibial baseplate, lot: 26150810; catalog: unk_ofl, description: unknown cemented femoral component, lot: unknown.At this time, it cannot be determined which, if any of the reported devices may have caused or contributed to the patient's experience.Not returned.

Event Description

It was reported that patient's knee was revised.Patient was revised to a triathlon ts knee construct.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 3-10MM
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• 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: 8017230
• MDR Text Key: 125429061
• Report Number: 3005985723-2018-00620
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000875
• UDI-Public: 00848486000875
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 180703-3
• Device Lot Number: 12120209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 64