MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT- SZ 4- 9MM; COMPARTMENTAL KNEE PROSTHESIS

Catalog Number 180704-2

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 01/19/2015

Event Type  Injury  

Event Description

A patient had received a partial knee arthroplasty, which was performed using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.Approximately one month later, the patient presented with signs of a possible infection, and the surgeon performed an incision and drainage (i&d) procedure and exchanged the tibial onlay insert component.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted if additional information becomes available.Device not returned; discarded.

Manufacturer Narrative

An event regarding infection involving a restoris mck insert was reported.The event was not confirmed.Device evaluation could not be performed as the subject device was not returned.Medical records received and evaluation: no medical records were 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: a complaint history review was not performed as no device specific failure modes were identified.Conclusions: infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting, however, the event could not be confirmed nor the root cause determined due to the minimal information received.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

A patient had received a partial knee arthroplasty, which was performed using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.Approximately one month later, the patient presented with signs of a possible infection, and the surgeon performed an incision and drainage (i&d) procedure and exchanged the tibial onlay insert component.

• Brand Name: MCK TIBIAL ONLAY INSERT- SZ 4- 9MM
• Type of Device: COMPARTMENTAL KNEE PROSTHESIS
• 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: 4538105
• MDR Text Key: 20785195
• Report Number: 3005985723-2015-00016
• Device Sequence Number: 1
• Product Code: KRR
• 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: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2016
• Device Catalogue Number: 180704-2
• Device Lot Number: 12020611-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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): Required Intervention