MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL-LM-RL-SZ 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180505

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 02/27/2017

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the hospital and was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Pain, bone scan shows mildly increased uptake in femoral component.Dx femoral loosening, left knee.

Manufacturer Narrative

An event regarding pain & loosening involving a mck femoral lm-rl sz 5 was reported.The event was not confirmed.Method & results: -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 records were submitted to a clinician, after reviewing, who stated that - "no x-ray or bone scan images or reports are available for review.There is no confirmation of the ¿osteopetrosis¿ diagnosis noted in the revision operative report and no confirmation of a loose femoral component as being present or the cause of persistent left knee pain of several years noted in the revision operative report.After only fifteen months¿ status-post index uni-compartment knee arthroplasty surgery, there is no evidence that factors related to the primary uka components were responsible for this clinical situation." -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 have been no other events for this lot.Conclusions: it was reported that patient was revised due to pain & loosening of femoral component.The provided medical records were submitted to a clinician, after reviewing, who stated that - "no x-ray or bone scan images or reports are available for review.There is no confirmation of the ¿osteopetrosis¿ diagnosis noted in the revision operative report and no confirmation of a loose femoral component as being present or the cause of persistent left knee pain of several years noted in the revision operative report.After only fifteen months¿ status-post index uni-compartment knee arthroplasty surgery, there is no evidence that factors related to the primary uka components were responsible for this clinical situation." thus, neither the event could be confirmed nor the root cause could be determined due to the minimal information received for evaluation.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

Pain - bone scan shows mildly increased uptake in femoral component - dx femoral loosening - left knee.

• Brand Name: MCK FEMORAL-LM-RL-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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6437293
• MDR Text Key: 70970132
• Report Number: 3005985723-2017-00144
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

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: 07/22/2016
• Device Catalogue Number: 180505
• Device Lot Number: 263808611-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2011
• 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; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 117