MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 5-9MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180705-2

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

The following other devices were also listed in this report: mck tibial baseplate-lm/rl-sz 5; cat# 180605; lot# 26100314-01.Mck femoral-lm-rl-sz 3; cat# 180503; lot# 228246k-1.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

The patient originally had surgery on (b)(6) 2014 and then came back for infection and had an i&d with a tibial insert exchange on (b)(6) 2014.

Manufacturer Narrative

Reported event: an event regarding infection involving a mck tibial onlay insert-sz 5-9mm was reported.The event was not confirmed.Method and results: device evaluation and results: could not be performed as no items associated with the event were returned for evaluation.Medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated "no patient demographics, no bacteriology results, no operative report for the revision to the total knee arthroplasty, and no examination of the explanted uka components are available.There is no evidence this clinical situation resulted from factors of faulty uka component design, manufacturing or materials.As noted in the event descriptions, revision to tka resulted from periprosthetic infection of the primary uka." device history review indicated the devices accepted into final stock from the reported lots were free from discrepancies.Complaint history review: there has been no other event for the lots referenced.Conclusions: the source of the infection could not be determined as patient information, clinical history, and results of bloodwork for infection were not provided.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information and/or devices become available, this investigation will be reopened.Product surveillance will continue to monitor for trends.

Event Description

The patient originally had surgery on (b)(6) 2014 and then came back for infection and had an i&d with a tibial insert exchange on (b)(6) 2014.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 5-9MM
• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5621059
• MDR Text Key: 44118758
• Report Number: 3005985723-2016-00136
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 180705-2
• Device Lot Number: 12030414-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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: 79 YR