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 Noise, Audible (3273)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 03/13/2017

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: mck femoral-lm-rl-sz 5; cat# 180505; lot# 26121011-01.Mck tibial baseplate-lm/rl-sz 5; cat# 180605; lot# 26330210.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.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.

Event Description

Left knee: patient called regarding bilateral makoplasty inserts, surgery (b)(6) 2013 both.Surgery went well.Between (b)(6) 2014 both knees started to get sore.Saw surgeon several times, xrays shows everything was fine but still sore, did exercise during physical therapy.Went to a second surgeon for another opinion of which during the physical exam the surgeon could hear rattling.Quality of life is diminishing as a result of his knees and unable to walk for long periods, esp up & down the stairs.Told to wear a brace which he says doesn't help or do a revision surgery.He stated that there is loosing.

Manufacturer Narrative

An event regarding patient factors (progression of osteoarthritis) involving a mako insert was reported.The event was confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated: "an office visit of (b)(6) 2013 notes the patient to be having diffuse macular rash & very happy with his surgery.When seen on (b)(6) 2013 it was noted, knees are doing fantastic & rash where skin in contact with adhesive & 0¿ to 125¿ bilaterally.On (b)(6) 2013 the office note states, very happy with outcome & golfing and climbing ladders & x-ray bilateral good alignment, no loosening.On (b)(6) 2014 it was noted, complains of both knees in constant pain & left greater than right & since started new job (b)(6) 2014.Prolonged standing on cement floors & by 1pm to 2pm very bothersome & bilateral medial joint line tenderness & x-ray unchanged & treat with rest, ice, knee sleeve, topical voltaren.On his visit of (b)(6) 2014 it was noted, increased left knee pain of three days duration and low back pain & left 0¿ too 130¿ with medial joint line tenderness, no erythema or warmth & x-ray left knee unchanged.When seen on (b)(6) 2014 he complains of low back pain; no complaints of knees & normal gait & mri disc bulging and foraminal stenosis l4 through s1.On (b)(6) 2015 he was seen in follow-up for his low back pain.When seen on (b)(6) 2015 he complained of all over, left greater than right , knee pain.The note continues, & bilateral 0¿ to 130¿ with no effusion, no ecchymosis.Left knee x-ray unremarkable.On (b)(6) 2016 he was seen complaining of bilateral knee pain, right 8 over 10, and left, 9 over 10, & back still painful & physical examination bilaterally no effusion, ecchymosis, patella femoral or medial joint line pain or tenderness & x-ray unchanged bilaterally.Consider bone scan or new scope at follow-up in two months.A (b)(6) 2016 bone scan report states, bilaterally no intense uptake is seen to suggest loosening/infection.On (b)(6) 2017 he was seen complaining of bilateral knee pain, 8 over 10, & status-post l5 through s1 disc surgery & complains of ankle pain & voltaren gel and brace helps ankle & knees bilaterally 0¿ to 125¿ with no effusion, no erythema.Laxity with valgus of the mcl is noted on the left, greater than the right.Plan: brace, consider increased insert thickness or conversion to a total knee arthroplasty.X-ray is unchanged.There is no documented follow-up subsequent to this visit available.There is no follow-up subsequent to (b)(6) 2017 and no x-rays available for review.Based upon the information available, there is no evidence that factors of fault component design, manufacturing or materials are responsible for this clinical situation.Soft tissue imbalance and progression of osteoarthritis to the other compartments are the most likely sources of the symptoms described in this case." device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the event reported that the patient was experiencing pain and loosening in his left knee.The provided medical records were reviewed by a consulting clinician who indicated that soft tissue imbalance and progression of osteoarthritis to the other compartments are the most likely sources of the symptoms described in this case but bilaterally no intense uptake is seen to suggest loosening/infection.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Left knee: patient called regarding bilateral makoplasty inserts, surgery (b)(6) 2013 both.Surgery went well.Between (b)(6) 2014 both knees started to get sore.Saw surgeon several times, xrays shows everything was fine but still sore, did exercise during physical therapy.Went to a second surgeon for another opinion of which during the physical exam the surgeon could hear rattling.Quality of life is diminishing as a result of his knees and unable to walk for long periods, especially up & down the stairs.He stated that there is loosing.

• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6476903
• MDR Text Key: 72263879
• Report Number: 0002249697-2017-01171
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 180705-1
• Device Lot Number: 12181011-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2011
• 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
• Patient Age: 62 YR
• Patient Weight: 74