MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 3-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180703-1

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 05/11/2016

Event Type  Injury  

Manufacturer Narrative

The following other devices were also listed in this report: mck femoral-rm-ll-sz 2; cat# 180512; lot# 234708k-1; mck tibial baseplate-rm/ll-sz 3; cat# 180613; lot# 26040215-01.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.Not returned to the manufacturer.

Event Description

Dr.(b)(6) revised a mako right medial uni knee to a primary tka.He said patient had pain.He said he saw nothing of concern when he revised the knee as far as much more advanced disease.No implant loosening or excessive wear.

Manufacturer Narrative

An event regarding pain & revision involving a mako insert was reported.The event was confirmed.Method & results: -device evaluation 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 fact that patello-femoral debridement was required at the primary uni-compartmental arthroplasty increases the likelihood that persistent and progressive osteoarthritis of the other compartments would cause pain and conversion to a total knee.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation." -device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the reported lot.Conclusions: a review of the provided medical records by a clinical consultant indicated "the fact that patellofemoral debridement was required at the primary unicompartmental arthroplasty increases the likelihood that persistent and progressive osteoarthritis of the other compartments would cause pain and conversion to a total knee.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.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) revised a mako right medial uni knee to a primary tka.He said patient had pain.He said he saw nothing of concern when he revised the knee as far as much more advanced disease.No implant loosening or excessive wear.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 3-8MM
• 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: 5704645
• MDR Text Key: 46765029
• Report Number: 3005985723-2016-00179
• 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: 12/18/2016

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: 03/31/2020
• Device Catalogue Number: 180703-1
• Device Lot Number: 12470315-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 06/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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