MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180615

Device Problem Insufficient Information (3190)

Patient Problems Arthritis (1723); Pain (1994)

Event Date 08/28/2017

Event Type  Injury  

Manufacturer Narrative

The following other devices were also listed in this report: mck tibial onlay insert-sz 5-8mm; cat#: 180705-1; lot#: 12010216-1.Mck femoral-rm-ll-sz 5; cat#: 180515; lot#: 26040815-01.Mck patellofemoral-r-sz 4; cat#: 180414; lot#: 2310651-1.Mck patella resurfacing round dome-29mm; cat#: 180320-2; lot#: 12520315-1.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient reports occasional lateral knee pain and anterior fat pad impingement after excessive weight bearing on their right knee.

Manufacturer Narrative

An event regarding pain involving a mako baseplate was reported.The event was not confirmed.Device evaluation and results: visual, dimensional and functional inspection were not performed as the item was not returned.Medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated that "no clinical or past medical history and no documented post-operative follow-up or description of symptoms are available for review.Lateral knee pain likely represents progression of arthritis in the non-replaced compartment of the right knee.There is no evidence that factors associated with design, manufacturing or materials of the implanted components are responsible for the symptoms described in the event description." device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been no other event for this lot.Conclusions: it was reported that patient had occasional lateral knee pain & anterior fat pad impingement after excessive weight bearing in right knee.The event could not be confirmed nor the root cause determined since the devices were not returned for evaluation and insufficient information was provided.The provided medical information was submitted to a consulting clinician who indicated that no clinical or past medical history and no documented post-operative follow-up or description of symptoms are available for review.Lateral knee pain likely represents progression of arthritis in the non-replaced compartment of the right knee.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.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Patient reports occasional lateral knee pain and anterior fat pad impingement after excessive weight bearing on their right knee.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 5
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6912784
• MDR Text Key: 88125528
• Report Number: 3005985723-2017-00472
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2021
• Device Catalogue Number: 180615
• Device Lot Number: 26071215-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2016
• 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): Other
• Patient Age: 71 YR
• Patient Weight: 82