MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 4; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Model Number 180614

Device Problem Loss of Osseointegration (2408)

Patient Problems Fall (1848); Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646)

Event Date 12/27/2019

Event Type  Injury  

Event Description

As per patient's voicemail: patient stated he had a tka on (b)(6) 2019.Patient stated he is unable to walk.Update as per patient: patient stated he had a pka on (b)(6) 2019.Patient was taken to the recovery room and was told he had to see a pt.He asked the nurse to use the bathroom because he couldn't get out of bed, he was told he couldn't use the bathroom as he had to do pt first.The patient asked for a percocet for pain and he was told he couldn't get one until after pt.The physical therapist also told him that he couldn't use the restroom until he had pt.The physical therapist assisted him to the bathroom after pt was done.While the physical therapist was assisting, he let go of the gate belt and the patient fell on the leg that was operated on.The physical therapist assisted the patient to the bed and told the patient that he was going to report the fall and get in touch with the physicians assistant.1-2 hours later the physician assistants came to check on the patient and the patient told them of the fall.The physicians checked the wound and the patient was discharged.The patient was told if he experiences any symptoms to call them.Patient stated that his wife was present and witness the whole incident.The next day the patient got up to use the bathroom and heard a pop.His wife called the surgeons office and was told that the popping was due to scar tissue.1-2 days after the patient was home from surgery he called the surgeon as he was experiencing excruciating pain he felt as his leg was on fire.The patient was prescribed percocet.2-3 days later the patient was still experiencing excruciating patient his wife took him to a walk-in emergence clinic.He was given an x-ray and was told that he might have an infection and was prescribed antibiotics and pain medication.12 days later he saw his surgeon.The patient stated the surgeon was upset at him as he was on a walker.The surgeon did an x-ray and told the patient that it looked good.His wife told the surgeon that the reason he was using the walker was because of the fall but the surgeon told them that it wasn't that every patient is different some take longer than others.The patient was told to come back in 8 weeks for a follow up.Patient was on pt for about two months.On (b)(6) 2020 the patient went to another surgeon for a second opinion and the surgeon performed an mri and told the patient there's a possible loosening of component that's causing his symptoms.The surgeon recommended revision surgery.The patient lost his job, 6 weeks vacation and insurance.Patient would like to also know why our ct micro scan guidelines weren't used appropriately.The patient stated that per guidelines you need 1-2 weeks prior to surgery and he was only given 2 hrs.The patient is seeking compensation for all his loss and pain.

Manufacturer Narrative

Reported event: an event regarding infection and loosening involving a mako baseplate was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: this inquiry reports the case of a painful medial unicompartmental knee replacement that appears to have failed due to early loosening, complicated by the presence of reflex sympathetic dystrophy.I cannot confirm that failure of the implant took place since i was not able to see appropriate corroborating radiographs and revision surgery has not been reported.Mri and bone scan studies are suggestive, but not diagnostic of, definite loosening.Pain from reflex sympathetic dystrophy can also be a source of significant pain and disability after knee arthroplasty.If loosening has occurred, early failure in this mode can be due to surgical technique factors and patient factors.In this case a fall in the immediate post-operative period was reported.Regarding the possible root cause of this event, it is unclear of whether the failed procedure is due to surgical technique issues, loosening or patient factors so i cannot comment on the root cause.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.There have been no other similar events for the sterile lot referenced.Conclusions: the patient reported that he was unable to walk, had issue with pain and instability and had a fall.He was told that he might have an infection and was prescribed antibiotics and pain medication.On (b)(6) 2021 a bone scan revealed evidence of loosening of his prosthesis.On (b)(6) 2021 the surgeon felt that in addition to loosening, the patient had reflex sympathetic dystrophy.The reported event was not confirmed.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Device not returned.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 4
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 13573588
• MDR Text Key: 287614092
• Report Number: 3005985723-2022-00015
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000776
• UDI-Public: 00848486000776
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 180614
• Device Catalogue Number: 180614
• Device Lot Number: 26190419-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 105 KG