MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 5-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180705-1

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 04/13/2016

Event Type  Injury  

Manufacturer Narrative

The following other device was also listed in this report: mck femoral-rm-ll-sz 3; cat# 180513; lot# 26080815-01, mck tibial baseplate-rm/ll-sz 5; cat# 180615; lot# 26060215-02 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 retained by the hospital 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.

Event Description

Dr.(b)(6) performed an i&d with a tibial insert swap on a mako pka patient right knee originally done on (b)(6) 2016 due to infection.

Manufacturer Narrative

An event regarding infection involving a mako insert was reported.The event was not confirmed.Method and results: device evaluation and results: could not be performed as the subject device was not returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: "the primary harm involved is early infection s/p unicompartmental knee replacement.Standard of care is for removal of the modular plastic insert to allow for a thorough irrigation and debridement and then replacement of the insert with a new sterile component.There is no evidence for an implant or manufacturing defect.There is insufficient documentation presented to complete this assessment." device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: a review of the provided medical records by a clinical consultant indicated "the primary harm involved is early infection s/p unicompartmental knee replacement.Standard of care is for removal of the modular plastic insert to allow for a thorough irrigation and debridement and then replacement of the insert with a new sterile component.There is no evidence for an implant or manufacturing defect.There is insufficient documentation presented to complete this assessment." no further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices or additional information become available, this investigation will be reopened.

Event Description

Dr.(b)(6) performed an i&d with a tibial insert swap on a mako pka patient right knee originally done on (b)(6) 2016 due to infection.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 5-8MM
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5647409
• MDR Text Key: 45009461
• Report Number: 3005985723-2016-00154
• 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: 04/13/2016

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: 12/07/2020
• Device Catalogue Number: 180705-1
• Device Lot Number: 12011115-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 05/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2015
• 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: 66 YR