MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 6-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180706-1

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 11/06/2015

Event Type  Injury  

Manufacturer Narrative

The following other devices were also listed in this report: mck tibial baseplate-lm/rl-sz 6; cat# 180606; lot# 26160214-01.Mck femoral-lm-rl-sz 5; cat# 180505; lot# 415610-m.It cannot be determined which, if any of these devices may have caused or contributed to the patient's pain.An evaluation of the device cannot be performed as the device 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 a revision on a previous medial mako knee to a total knee replacement.Patient revised due to persistent pain in left knee.

Manufacturer Narrative

An event regarding pain involving a mako insert was reported.The event was not confirmed.Method and results: medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: the most common reason for persistent pain requiring revision of a unicondylar to a total knee arthroplasty is progression of osteoarthritis to the other knee compartments.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.Device history review: indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: not performed as no device specific failure modes were identified.Conclusions: a review of the provided records by a clinical consultant indicated there is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.A capa trend analysis was conducted for the reported failure mode and concluded pain may result from other factors not necessarily related to the device.Product surveillance will continue to monitor for trends.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Dr.(b)(6) performed a revision on a previous medial mako knee to a total knee replacement.Patient revised due to persistent pain in left knee.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 6-8MM
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5248519
• MDR Text Key: 32097115
• Report Number: 3005985723-2015-00278
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 180706-1
• Device Lot Number: 12060414-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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: 70 YR