MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT- SZ 2- 10MM; IMPLANT

Catalog Number 180702-3

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 04/24/2015

Event Type  Injury  

Event Description

An i&d was performed on an infected right lateral knee by dr.(b)(6) and thus the tibial onlay insert implant was extracted and replaced with a new one.The original dos was (b)(6) 2015 by dr.(b)(6).

Manufacturer Narrative

The following other devices were also listed in this report: mck tibial baseplate- lm/rl- sz 2; cat# 180602; lot# 26110314-01; mck femoral- lm-rl- sz 3; cat# 80503; lot# 434809-m.It cannot be determined which, if any of these devices may have caused or contributed to the patient's infection.An evaluation of the device cannot be performed as the device was discarded and was not returned to the manufacturer.Additional information has been requested.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

The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

An i&d was performed on an infected right lateral knee by dr.(b)(6) and thus the tibial onlay insert implant was extracted and replaced with a new one.The original dos was (b)(6) 2015 by dr.(b)(6).

• Brand Name: MCK TIBIAL ONLAY INSERT- SZ 2- 10MM
• 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: 4791689
• MDR Text Key: 19092741
• Report Number: 3005985723-2015-00084
• 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
• Report Date: 04/24/2015

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: 12/31/2017
• Device Catalogue Number: 180702-3
• Device Lot Number: 12031212-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2012
• 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: 75 YR